Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Role

Working within the Quality function for PCI Pharma Services (Ireland Sites) Quality Product(s) Lead will be primarily responsible for managing the quality element of New Product Introduction (NPI) and large-scale programmes relating to one Client consisting of one or more projects, each with varying complexity. A sound collaborator and natural leader, the Quality Product(s) Lead will display interpersonal and communication skills that build the strongest of relationships at site and customer levels. Whilst agile and customer focused, they will be a proven talent for identifying the quality needs of the project and ensuring regulatory compliance through the project/programme lifecycle.

Quality Product(s) Lead will have a proven track record in the ability to communicate and escalate effectively, be strong in team management and possess excellent coordination skills.

Key Responsibilities

• Ensure compliance with cGMP, corporate standards/PCI Quality System (PQS), site policies/procedures, regulatory requirements, and industry standards.
• Partner closely with customers and stakeholders to understand and deliver on all records within timelines and escalate when necessary.

• Participate in cross functional teams as required to provide consultative support on quality related issues and documentation management.
• Ensure that operational instructional documentation are up to date, compliant, and supports efficient production.
• Main point of Contact for all Quality escalations from Customers.
• To ensure that products/devices are packaged and controlled to meet the requisite safety and quality and GMP standards.
• Communicate regularly and effectively. Work cross functionally to ensure communication within the business is always up-to-date and utilises all available channels.
• Work closely with the Programme Manager and cross functional teams to define the programme strategy, scope and objectives. 
• Working with the programme and project managers manage project timelines to ensure Quality elements of projects are delivered on time and critical paths are identified and monitored throughout their lifecycle.
• Promote engagement at all levels and stages of the programme. Encourage individuals to contribute to the success of each project and illustrate benefits brought about.
• Manage risks within the programme. Ensure risks are identified, evaluated, and controlled through the programme lifecycle.
• Follow and comply with the NPI process as per company procedures and policies.
• Display strong leadership to the various project teams from concept to handover. Lead by example in day-to-day project and team management.
• Manage change at varying levels ensuring site procedures are followed and change controls are raised at the appropriate time with the relevant approvers engaged from the outset.
• Create and sustain a working environment that promotes the PCI Values and Behaviours.
• To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.
• Work with Customer to define KPI’s and lead reporting of KPI’s to Site and Customer Teams
• Quality Product(s) Lead is responsible for adhering to the company’s SOPs, Health & Safety, cGMP and other regulatory guidelines themselves and for team members and contractors under their control.
• Quality Product(s) Lead is responsible for the quality element of all new products/devices and their associated project phases.
• It is a requirement of this role that on occasion the individual will be required to travel on company business. This may be vendor/supplier or customer based.

Knowledge / Skills & Experience

Essential:

• To have demonstrable experience within New Product Introduction (NPI) and Quality governance of same
• To have experience of medical device assemby
• Experience of quality critical activities within the pharmaceutical industry
• Sound working knowledge of cGMP
• Experience of working directly with customers as the single point of contact
• Experience of working at management level within a similar environment an advantage.
• Experience of managing a technical/quality team
• Strong insight into the pharmaceutical customer requirements relating to speed to market, NPI and service
• Industry knowledge of the requirements of EU GMP and ISO requirements for Medical Devices
• 5 years’ experience working in Quality pharmaceutical or medical device role.  
• Educated to EQF (European Qualifications Framework) level 6 in a Technical, Engineering or a Science subject.
• Master’s degree (or higher) in a Technical, Engineering or a Science subject.
• Proficient utilisation of software packages such as Excel, Word, PowerPoint, Project and Visio and a high level of computer literacy.
• Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company

Desirable:

• 5+ years experience working in Pharmaceutical packaging organisation or similar in medical device organisation with at Least 2 in a senior role
• Experience in a GMP or Regulated Environment.
• Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.