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Janssen Pharmaceutica NV, a member of Johnson & Johnson's Family of Companies, is looking for a senior QA associate to strengthen the Product Quality Management - Clinical Supply Quality team! We are a motivated team guaranteeing the quality oversight over multiple and complex clinical supply chains for innovative products in the Janssen portfolio covering small and large molecules, vaccines, and advanced therapies medicinal products (ATMP). One of our main responsibilities is the release and certification of investigational medicinal products used in worldwide clinical trials so that patient safety & compliance with applicable regulations are warranted. We are continuously adapting and improving our quality processes to accommodate the needs of the compounds with the ultimate goal of providing hope in a box to our patients.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our innovative products? Apply today for this exciting opportunity!

As a Delegate Qualified Person Clinical Supply Quality you will:

• Perform batch release for clinical trial material in scope of the IMP license of Janssen R&D, a division of Janssen Pharmaceutica NV.
• Closely collaborate with CSC groups and global departments such as ECSQ (External Clinical Supply Quality), QAM (Quality Asset Management) and PES (Partnership & External Supply) to obtain all vital inputs for a timely release and QP certification in support of a reliable supply chain.

• Represent QA Clinical Supply Chain (CSC) in different teams. Ensure the needs of clinical supply quality are embedded from the start of clinical trial execution.

• Act as an expert resource in assessing and maintaining quality and compliance levels. Thereby ensuring compliance with the GMP and GDP requirements, the clinical trial directive/regulation and other legislation in a clinical trial environment. Support the operational departments by providing coaching and/or training.
• Ensure quality oversight of the operational activities by QA approval of GMP documentation, including quality agreements, and support/participation in the different quality review meetings.
• Ensure that deviations/complaints are timely and accurately investigated such that the internal and external customer expectations and Quality & Compliance levels are met. Support in-depth investigations by providing technical, Q&C expertise, and ensure that adequate CAPA’s are defined for investigations with potential quality impact. Ensure that deviations/complaints with potential impact on patients and/or product supply are properly escalated.
• Continuously challenge the status quo and ensure sustainability of organizational, quality and compliance performance.
• Take accountability of implementation and execution of different quality system processes.
• Act as spokesperson during Health Authority inspections and customer audits.

• Support operational quality performance by participating in different quality review meetings.

Qualifications:

·      University degree, Industrial Pharmacist – EU certified Qualified Person is a must.

·      At least 3 years’ experience in pharmaceutical supply chain and/or quality assurance.

·      Experience in product release is an asset.

Experience and Skills:

• Experience as release responsible in product development, and/or in operational quality and/or production related expertise are an asset.
• In depth understanding of (sterile) pharmaceutical production are an asset.
• Experience with Quality Systems and regulatory inspections and preparedness. In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards, and procedures.
• Able to work independently while managing stakeholders, to handle complexity, and to take ownership for deliverables, as well as flexibility and confirmed collaboration skills, are required.

• Strong communication and interpersonal skills, a high level of organizational agility and ability to work effectively in a collaborative environment globally (US and EU) is required. Good written and verbal communication skills

• Able to quickly assimilate new technologies, perform risk assessment and develop action plans.

·      Understand the business implications regarding quality positions and decisions. Understand the bigger picture.

• Able to think outside the box and come up with innovative and creative solutions to problems. Open-minded for new ideas and willing to pivot when necessary.

• Able to adjust plans and priorities when circumstances change, to prioritize tasks and manage time effectively, and to show resilience in difficult situations.

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The anticipated base pay range for this position is:

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.