Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for an Associate, Supply Chain Material Coordinator to join one of our partner companies, a large pharmaceutical company in Belgium. This is an office-based role, in Mont Saint-Guibert, Belgium.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Scope of the role:

The Supply Chain Material Coordinator is responsible for the coordination and procurement of packaging materials and drug product for Clinical Trial Materials. The CT function has the responsibility for the ordering, manufacturing, packaging, shipment, and inventory management of supplies for clinical studies worldwide. The organization produces custom-designed trial materials under full GMP regulations.

Main Job Tasks and Responsibilities:

• Accountable for MRP actions from the point of purchase order or stock transfer order creation through successful batch disposition.
• Participate in material movement planning meetings.
• Own all order fulfilment activities from customer request through material delivery including documentation, delivery schedule, and priorities.
• Responsible for inventory management including disposition of expired materials.
• Promptly address inquiries received from CPs.
• Provide operations support to the FING Packaging Plant Planning function.
• Troubleshoot and resolve purchasing, material fulfilment or operational level issues as they arise.
• Identify and participate in projects or assignments to improve productivity, compliance, and data accuracy.
• Author deviations, change controls and perform investigations as necessary
• Managing vendor relationships and issue resolution.
• KPI’s and metrics generation.

Education and Experience:

• B.S. in Pharmacy, Pharmaceutical Sciences, Chemical/Biochemical Engineering or related field / experience.
• Experience in managing inventory/supplies or complex supply chains.
• Knowledge of clinical trial packaging.
• Demonstrated exemplary teamwork/interpersonal skills.
• Strong organization and self-management skills.
• Ability to use and apply multiple computer applications.
• Ability to manage multiple tasks and respond to change.
• Effective written and verbal communication skills in multi-cultural settings.
• High initiative, flexible and positive attitude.
• High degree of accuracy with work and attentive to details.
• Ability to proactively identify problems and work toward a solution.
• Minimum 1 year in a GMP environment.

Additional Preferences:

• Clinical research/study knowledge.
• Prior experience with SAP is preferred.
• Data analysis and Excel experience.
• Fluent in English language.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.       

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Associate Supply Chain, Clinical Trial, Labelling, Shipment, Packaging, GMP, English, CRO, Contract Research Organization, Outsourced, Outsourcing, Sponsor-dedicated.

#LI-CM1 #TEMPORARY

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Quality Engineer SM-API to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work at Geel, office, until the end of December 2026.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Scope of the role:

Within Supply Chain Quality (SCQ) Geel, as a Quality Engineer SM-API, you are a key partner for Operations and Quality. You provide quality advice, review GMP documentation, and oversee the handling of non-conformances and corrective/improvement actions so that the timely release of our commercial API product portfolio can be achieved in compliance with applicable regulations.

Main Job Tasks and Responsibilities:

• Review and approval of non-conformances and CAPAs in support of the QA commercial Operations team.
• Review and approve GMP documentation such as procedures, work instructions, protocols and reports.
• Provide quality support to the production plants.
• Ensure that quality records (e.g., Change Controls) are processed on time and in compliance by providing quality, compliance and technical expertise.
• Participate in QA check rounds.
• Support for smaller optimization projects and tasks within the QA Commercial Operations team.
• Establish and maintain strong working relationships with Business and Quality partners.
  

Education and Experience:

• Master Scientific degree (chemistry, pharmaceutical sciences, bioengineer).
• Experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance and experience as release responsible is an asset.
• Experience in non-conformance handling is a must.
• In-depth understanding of pharmaceutical product development, qualification, validation, manufacturing, packaging, labelling, testing, release, storage and distribution processes.
• Demonstrated ability to work independently while staying connected with key stakeholders.
• Strong analytical and solution-oriented mindset; able to work flexibly under time pressure.
• Ability to make risk-based decisions under time pressure.
• In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.
• Experience with Quality Systems.
• Fluent in English and Dutch (spoken and written).

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.       

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Quality Engineer SM-API, Quality Assurance, Supply Chain, GMP, CAPA, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

#LI-CM1 #LI-TEMPORARY

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…

ClinChoice is searching for a Distribution Material Coordinator to work with one of our partner pharmaceutical companies. This is a full-time (1 FTE), permanent position to be hybrid at our client’s site in Mont Saint Guibert for 2 days per week.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

The Distribution Material Coordinator will ensure that clinical trial materials are delivered to patients on time and in optimal condition worldwide, leveraging a network of third party distribution partners. This role will support the approval of new drugs by ensuring robust documentation and addressing any patient risk. In addition, they will be responsible for the compliant and timely movement of clinical trial materials, from initial reception at the distribution hubs, through transfers to other hubs or depots, and finally to clinical sites. This will include overseeing material management during all hub/depot operations.

Main Job Tasks and Responsibilities:

• Oversee all operations performed by hubs/depots, including reception, shipments, labelling and inventory management, in partnership with Quality, Clinical, and hub/depot teams.
• Collaborate with cross-functional teams to understand delivery schedules and priorities, ensuring timely fulfilment at hubs/depots.
• Monitor SAP/KorberOne delivery lists, resolve shipment issues, and conduct investigations as needed.
• Approve Quality Notification Forms from Collaboration Partners and create internal records per procedural requirements (e.g.: external deviations, CART, distribution complaints, change controls).
• Keep accuracy and consistency across SAP, KorberOne, and IWRS systems, addressing system message or interface issues.
• Participate in the creation, update, and training of clinical trial distribution processes.
• Maintain distribution networks diagrams and P-Info records.
• Push Outbound Deliveries from SAP to KorberOne as required.
• Create purchase orders and review/approve invoices for distribution vendors as required.
• Ensure completion of any pre-shipment paperwork and ensure necessary import requirements are in place prior to shipment execution
• Proactively identify and implement improvements in daily activities to support productivity, efficiency, and risk reduction.
• Make Fit For Use determinations in case of temperature excursions.
• Author deviations and change controls and perform investigations as necessary to address departures from SOPs.
• Participate in the creation and update of clinical trial distribution processes and provide training to clients.
• Support efforts and projects to improve productivity, efficiency, product quality, and risk reduction or linked to distribution process change.
• Ensure material set-up in KorberOne for items not packaged by Product Delivery.
• Participate in visits to hubs/depots and affiliates and support conference calls/meeting as needed
• Participate in projects linked to distribution process changes, including associated change controls.
• Ensure compliance with GMP/GDP and all internal/external regulatory requirements for importation, warehousing, labelling, and distribution activities for all product types.
• Ensure all activities comply with company safety, environmental, and confidentiality requirements.
• Maintain up-to-date individual training plans and follow procedures applicable to the clinical trial business.

Education, Experience and Skills:

• Bachelor degree, preferably in health care or supply chain/logistics field or equivalent work experience.
• Experience in managing inventory/supplies or complex supply chains
• Knowledge of clinical trial distribution, cGMP and experience in a highly regulated environment Customer and process focused
• Knowledge of global import/export requirements

• Clinical research/study expertise
• Prior experience with SAP
• Demonstrated exemplary teamwork/interpersonal skills
• Strong organization and self-management skills
• Ability to use and apply multiple computer applications
• Ability to manage multiple tasks and respond to change
• Effective written and verbal communication skills in multi-cultural settings
• High initiative, flexible and positive attitude
• High degree of accuracy with work and attentive to details
• Ability to proactively identify problems and work toward a solution
• Understands global shipping requirements, including country-specific requirements
• Must speak fluent English
  
  

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Distribution Materials Coordinator, Clinical Trial Materials, Clinical Trial Supply, Clinical Trial Distribution, CRO, Contract Research Organisation, Outsourced, Pharmaceutical, Pharma

#LI-LG1 #LI-Hybrid #Permanent

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Data Integrity Specialist, Quality Assurance Computer Systems Validation (CSV) to work with one of our partner biopharmaceutical companies. This is a full-time (1 FTE) temporary employment position to the end of 2026 initially.

The Data Integrity Specialist will focus on Innovative Medicine Supply Chain systems, primarily from our client in Beerse. Hybrid working with 2 days working from home per week is permitted.   

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Main Job Tasks and Responsibilities:

• Cooperate with multifunctional teams to assess local systems and equipment.
• Define risks and vulnerabilities for the local systems and equipment.
• Provide Data Integrity guidance and support towards local Subject Matter Experts.
• Define remediation activities and create Data Integrity plans.
• Act as local Process Owner for Data Integrity.
• Support the Small Molecules Data Integrity Community of Practice.
• Organize and lead sessions with Data Integrity representatives of multiple sites.
• Assist site Subject Matter Experts with the assessment process of all site specific systems and equipment.
• Assist Site Subject Matter Experts with Data Flow Mapping and Risk Assessments.
• Organize, manage and perform SM Platform based Data Flow Mapping and Risk Assessments.
• Maintain a current knowledge of international laws, guidelines and new evolutions related to Computer System Validation through courses, conferences, seminars, internal and external benchmarking and literature studies. Implement this knowledge to maintain and improve Computer System Validation at sponsor.
• Prepare for audits and inspections by regulatory agencies, customers and internal compliance team.
• Be an Subject Matter Expert for Data Integrity matters during audits and inspections.
• Cooperate with engineering, IT and other teams for the Data Integrity compliance during introduction of new systems, equipment and processes.
• Give advice and support for the preparation of Computer System Validation related activities and guard the cGMP aspects in new projects. Be a member of multi-functional teams to realize cross-departmental objectives.

Education, Experience and Skills:

·        Master scientific degree or equivalent experience.

·        3 years’ experience in the pharmaceutical industry.

·        Knowledge of cGMP/CSV compliance (21 CFR Parts 11, 210, 211; Eudralex 4, EU Directive 2003/94/EC, EU Directive 2017/1572 and annex 11; GAMP, Data Integrity Guidelines).

·        Strong ownership and Quality mindset. You are able to deliver on commitment timelines.

·        Ability to make risk-based decisions. Understands the business implications regarding quality positions and decisions.

·        Experience with Data Integrity remediation activities.

·        Experience with Computerized System Validation.

·        Fluent in verbal and written communication in English and Dutch and are able to connect with diverse partners.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Data Integrity Specialist, Computer Systems Validation, DIS, CSV, Quality Assurance, Temporary

#LI-LG1 #LI-Hybrid

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a CAR-T Quality Assurance Engineer to work with one of our partner biopharmaceutical companies. This is a full-time (1 FTE) temporary employment position to the end of 2026 initially.

The Engineer will be responsible for the review and approval of qualification and requalification activities, related to Facilities and Utilities and Process Equipment at our client’s facility in Ghent.  

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Main Job Tasks and Responsibilities:

• Work closely with the Make Asset Management and Engineering & Property Services department to guard the qualification status of critical production assets by ensuring that all system critical aspects related to facilities and utilities, product and process requirements are identified; qualified and controlled by a mitigation plan and ensure that deviations related to equipment issues with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventative actions are defined and implemented.
• Work closely together with the manufacturing department to approve new change controls and to ensure that deviations with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented.
• Build strong connections with different quality organizations.
• Manage the compliance status of critical production assets by means of review and approval of procedures e.g. calibration rationales, calibration master forms and completed calibration records, master data set-up, maintenance plans and follow up daily operations activities by review and approval of data integrity deliverables such as system audit trail and user access reviews.
• Participate in the preparation for regulatory and customer inspections and act as a spokesperson for Quality Assurance qualification.
• Approve qualification documents (change controls, master documents, protocols, reports, rationales, SOP’s, URS, IA, QSR, etc.) including discrepancies/events/non-conforming situations and related corrective actions (correction, CPA) occurring during execution of qualification activities.
• Participate in system and process improvement / optimization projects and assure quality and compliance aspects and maintain a current knowledge of international regulations, guidelines and industry practices and become the QA process expert.

Education, Experience and Skills:

·        Master’s degree in engineering with chemistry or analytical background or in pharmaceutical sciences

·        Awareness of quality; have knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell therapy products and you see it as a challenge to defend our strategy and documents towards health authority inspections.

·        Affinity with computerized systems, System parameter configurations and data management in critical production assets.

·        Ability to show and apply strong communication skills and are known as a great teammate who can work cross departmental in a continuous changing environment.

·        Thorough knowledge of Dutch and English, both orally and in writing

·        Strong analytical thinking, risk assessment, and communication skills

·        Collaboration and teaming skills

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Quality Assurance Engineer, CAR-T, QA Officer, Quality Officer, Quality Assurance Specialist, QA Specialist, Temporary#

#LI-LG1 

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Quality Assurance Analyst, Qualification Facility & Utility to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work at Geel office, until 31 December 2026.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Scope of the role:

In this role you will support the QA Engineering department in assuring that all Qualification related regulatory and procedural requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for Geel Facility and Utility systems.

Main Job Tasks and Responsibilities:

• Review and approve qualification documents & quality records such as SOPs, user requirements, impact/risks analysis’s, Test Plans, test scripts, change controls, CAPA’s etc. in order to maintain compliance to regulations, guidelines, and Company policies and standards.
• Be part of engineering teams and interact with other groups for the introduction of new/upgraded systems and processes. To give advice and support for the preparation of qualification related activities and guard the cGMP aspects.
• Address and follow-up of deviations occurred during execution of qualification activities.
• Communicate status (quality & compliance, planning) towards Company QA Qualification team members.

Education and Experience:

• University/Bachelor’s Degree or Equivalent.
• Experience in chemical and/or pharmaceutical industry with respect to qualification of equipment.
• Knowledge of cGMP regulations and guidelines.
• Capacity to ‘translate’ technical information into information that can be understood at every level of the organization.
• Being able to correctly estimate the urgency, criticality and impact of decisions related to the function.
• Ability to multi-task and work on a variety of projects at one time.
• Ability to work independently and work in cross-functional team environment.
• Good communication skills.
• Fluent in English and Dutch (spoken and written).
• Facility and Utility systems used within pharmaceutical or chemical industry.
• Problem report, change request systems. (f.e. Trackwise, Comet).
• Document Management systems (f.e. TruVault).
• Test tools (f.e. Kneat).

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.       

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Quality Assurance Analyst, Qualification Facility & Utility, Quality Management System, CAPA, GMP, Regulatory Compliance, Technical Documentation, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

#LI-CM1 #LI-ONSITE #TEMPORARY

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Quality Assurance Qualification Contractor to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work at Geel office, until 31 December 2026.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Scope of the role:

In this role you will support the QA Engineering department in assuring that all Qualification related regulatory and procedural requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for Geel manufacturing systems.

Main Job Tasks and Responsibilities:

• Review and approve qualification documents & quality records such as SOPs, user requirements, impact/risks analysis’s, Test Plans, test scripts, change controls, CAPA’s etc. in order to maintain compliance to regulations, guidelines, and Company policies and standards.
• Be part of engineering teams and interact with other groups for the introduction of new/upgraded systems and processes. To give advice and support for the preparation of qualification related activities and guard the cGMP aspects.
• Address and follow-up of deviations occurred during execution of qualification activities.
• Communicate status (quality & compliance, planning) towards Company QA Qualification team members.

Education and Experience:

• University/Bachelor’s Degree or Equivalent.
• Experience in chemical and/or pharmaceutical industry with respect to qualification of equipment.
• Knowledge of cGMP regulations and guidelines.
• Capacity to ‘translate’ technical information into information that can be understood at every level of the organization.
• Being able to correctly estimate the urgency, criticality and impact of decisions related to the function.
• Ability to multi-task and work on a variety of projects at one time.
• Ability to work independently and work in cross-functional team environment.
• Good communication skills.
• Fluent in English and Dutch (spoken and written).
• Manufacturing systems used within pharmaceutical or chemical industry.
• Problem report, change request systems. (f.e. Trackwise, Comet).
• Document Management systems (f.e. TruVault).
• Test tools (f.e. Kneat).

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.       

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Quality Assurance Qualification Contractor, Quality Management System, CAPA, GMP, Regulatory Compliance, Technical Documentation, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

#LI-CM1 #LI-ONSITE #TEMPORARY

Are you a CRA looking for the best of both worlds?

Would you like to work directly with a single sponsor while still enjoying the stability, global reach, and career development opportunities that come with working for a leading CRO? Our team calls it the best of both worlds — and we think you’ll agree.

ClinChoice is a rapidly growing global contract research organization. We’re currently expanding our CRA network in Belgium and are seeking skilled Clinical Research Associates (CRA II or Senior CRA) interested in partnering with some of the world’s leading pharmaceutical companies in the field of biomedicine.

If that sounds like you, we encourage you to submit your resume via our website — we’d love to hear from you!

As a CRA, you’ll manage clinical study activities across multiple sites within one or more projects, with a focus on medical devices. You will oversee site performance, conduct company-initiated clinical studies, and ensure high-quality deliverables through site visits, monitoring, and effective communication.

Key Requirements:

• Willingness to travel to sites and surrounding countries (50-80% travel).
• Fluent in English and Dutch is required.
• Prior experience in monitoring clinical trials and site management.

Join a dynamic, global team that values growth, collaboration, and making a difference in clinical research.

Skills and Qualifications:

• Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; Nursing degree or relevant degree or background preferred. In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Up to 8 years of experience as a CRA.
• Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements.
• Sound knowledge of medical terminology.
• Fluent in English and local language(s).
• Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).

Education and Experience:

• A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science, a Masters or PhD/MD/PharmD.
• At least 4 plus years of onsite monitoring experience is required.
• Previous medical device monitoring experience is required. Therapeutic area experience in neuro- or cardiovascular domain is also required.
• Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
• Clinical/medical background – a plus.
• Languages: Be able to converse and monitor in English and Dutch. Must be able to converse and understand the documentation, monitoring, etc. in a reasonably confident manner to monitor in that.
• Ability to travel up to 80%. 

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Senior Clinical Research Associate, Senior CRA, Freelance, Self-employed, Contract, Site Management, Monitor, Monitoring, Complex Trials, Medical Devices, Cardiology, Neurology, Open to Travel, Submissions, Ethics, Contract Research Organisation, CRO

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