Sr QA Release Responsible

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com.

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:

Geel, Antwerp, Belgium

Job Description:

Sr QA Release responsible / Site Qualified Person

At Johnson & Johnson Innovative Medicine, we believe quality is not just a function — it is a commitment to patients. Every release decision you make directly impacts the lives of patients worldwide.

We are looking for a Senior QA Release Responsible – DPi / Site Qualified Person (QP) to join our Quality organization and play a critical leadership role in safeguarding product quality, ensuring compliance, and enabling reliable supply. You will be a member of our QA Drug Product team overseeing Small Molecule Drug Product Intermediates (Synthetics) based in Geel, Belgium. You will be part of an enthusiastic team responsible for the quality oversight of the production plants and timely release of DPi’s, ensuring compliance with applicable regulations.

Innovative Medicine Supply Chain Geel serves as Centre of Excellence for the development and manufacturing of Spraydried Powders in Synthetics used in treatments that improve the health and lifestyle of people worldwide. Innovative Medicine Supply Chain Quality supports the Geel site in its mission as Launch & Grow site.

We are looking for a Senior QA Release Responsible – Site Qualified Person who is responsible to:

• Take end-to-end accountability as Site Qualified Person (QP) for batch release, ensuring compliance with EU GMP and regulatory requirements
• Provide independent QA oversight for Drug Product intermediate (DPi) operations, from manufacturing through release
• Make complex, risk-based decisions that balance patient safety, compliance and supply continuity
• Act as Quality lead and first point of contact for the Nebula program (new building with spray and postdrying), driving quality strategy, governance and cross-functional alignment
• Influence and partner with Operations, MSAT, Supply Chain and Regulatory to ensure alignment and successful delivery

• Build and sustain strong partnerships with Business and Quality stakeholders to ensure alignment of objectives and results. Promote and strengthen the quality culture by providing coaching and training on cGMP requirements.
• Ensure that non‑conformances, CAPAs, Change Controls, and Product Quality Complaints are thoroughly and timely investigated by providing quality, compliance, and technical expertise, meeting internal and external customer expectations.
• Ensure that non‑conformances and complaints with potential impact on patient safety and/or product supply are appropriately addressed and escalated.

• Represent Quality as a trusted spokesperson during inspections and audits
• Drive a culture of innovation within Quality activities by benchmarking, training, and participating in industry forums. Challenge the status quo by identifying opportunities for continuous improvement and lead the implementation of initiatives that enhance organizational, quality, and compliance performance.

Qualifications:

• Master Scientific degree (chemistry, pharmaceutical sciences, bioengineer, microbiology…).
• Industrial Pharmacist – EU certified Qualified Person
• At least 5 years’ experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance.
• Demonstrated ability to work independently while staying connected with key stakeholders.
• Strong analytical thinking skills, solution oriented thinking and able to work in a flexible way under time pressure. Ability to make risk based decision under time pressure. Understands the business implications regarding quality positions and decisions.
• Demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering. Negotiation, communication and presentation skills across all levels of the organization are important.
• In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.
• Experience with Quality Systems.
• Experience with regulatory inspections and preparedness.
• Project management skills

 

 

 

 

Required Skills:

 

 

Preferred Skills:

Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

  

 

The anticipated base pay range for this position is:

€72 500,00 - €115 230,00

 

 

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.