Mgr, Clinical Supply Chain Quality

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Beerse Antwerp Belgium

Job Description:

Janssen Pharmaceutica NV a member of Johnson & Johnsons Family of Companies is looking for a manager to strengthen the Clinical Supply Quality (CSQ) team! We are a motivated team ensuring quality oversight over multiple and complex clinical supply chains for innovative products including synthetics and biotherapeutics and advanced therapies. Our responsibilities include the certification and release of investigational medicinal products (IMPs) used in worldwide J&J sponsored clinical trials ensuring patient safety and compliance with applicable regulations.

In this role you will act as a Qualified Person (QP) delegate and Quality Point of Contact contributing to end-to-end quality oversight across the clinical supply chain with the ultimate goal of providing hope in a box to our patients.

Are you interested in making a meaningful impact on patients lives by ensuring the highest quality standards in innovative medicines Then we would like to hear from you.

Key Responsibilities

As a manager you will:

• Act as Qualified Person (QP) delegate responsible for certification and release of investigational medicinal products in accordance with EU GMP Annex 16 and Clinical Trial Regulation requirements

• Grow into a back-up Qualified Person (QP) role over time

• Serve as Clinical Supply Chain Quality Point of Contact for assigned product portfolios ensuring alignment of inputs required for timely QP release and certification

• Ensure compliant release of clinical trial materials by reviewing batch documentation analytical results and regulatory requirements across formulation filling packaging testing and storage activities

• Collaborate closely with Clinical Supply Chain (CSC) groups and global stakeholders (e.g. ECSQ PQM External Supply) to enable a reliable and compliant supply chain

• Represent CSQ in cross-functional teams and ensure quality requirements are embedded from early clinical trial execution onwards

• Provide quality oversight of operational activities including QA approval of GMP documentation (e.g. batch records quality agreements) and participation in quality review meetings

• Act as an expert in GMP/GDP and clinical trial regulations supporting operational teams through coaching and training

• Ensure timely and robust investigation of deviations and complaints including definition of appropriate CAPAs and acting as escalation lead for critical quality issues

• Support and represent CSQ during health authority inspections and internal/external audits including preparation execution and follow-up activities

• Drive continuous improvement initiatives identifying opportunities and implementing sustainable enhancements to quality systems and operational performance

• Monitor pharmaceutical industry trends and regulatory developments assess their impact and drive implementation of related process changes

• Coach and guide the team in risk identification mitigation planning data monitoring and development of meaningful KPIs

• Build and maintain effective working relationships with business and quality partners to align objectives and deliverables

Qualifications

• University degree in Pharmaceutical Sciences; EU-certified Qualified Person (QP) required

• Minimum 5 years of relevant experience in pharmaceutical quality assurance and/or clinical supply chain

• Experience with product release and QP certification is highly preferred

Experience and Skills

• Strong knowledge of cGMP GDP and clinical trial regulations including EU GMP Annex 16 and Clinical Trial Regulation (EU) No 536/20

• In depth understanding of (sterile) pharmaceutical production (manufacturing and packaging) and the specific technologies that are being applied qualification validation testing release

• Experience with quality systems inspections and audit readiness

• Solid understanding of the end-to-end pharmaceutical product lifecycle (development manufacturing testing release and distribution)

• Ability to act independently manage complexity and take ownership of deliverables in a global environment

• Strong stakeholder management and collaboration skills across cross-functional and international teams

• Excellent analytical thinking and decision-making capabilities with a clear understanding of business and quality implications

• Apply end-to-end thinking to ensure reliable efficient and compliant processes that support departmental strategic goals

• Effective communication skills both written and verbal

• Ability to drive improvements adapt to change and prioritize in a dynamic environment

• Demonstrates an understanding of AI concepts and frameworks including awareness of responsible and ethical AI practices and has experience generating effective prompts to boost efficiency and productivity

• Familiarity with systems such as SAP COMET eLIMS or similar is an asset

What We Offer

• A critical role in ensuring the quality and availability of innovative medicines for patients worldwide

• A collaborative global and purpose-driven environment

• Opportunities to contribute to complex clinical programs and continuous improvement initiatives

Required Skills:

Process Quality Assurance Quality Assurance (QA)

Preferred Skills:

Business Alignment Coaching Collaboration Compliance Management Continuous Improvement Fact-Based Decision Making Good Manufacturing Practices (GMP) ISO 9001 Process Improvements Quality Control (QC) Quality Management Systems (QMS) Quality Standards Quality Validation Regulatory Environment Standard Operating Procedure (SOP) Tactical Thinking Technical Credibility

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 locations 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.

Required Experience:

Manager

Employment Type : Full-Time
Experience: years
Vacancy: 1