Job Description

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

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Within Johnson & Johnson, Innovative Medicine Supply Chain, we are recruiting a QA Associate Commercial. You will be a member of our QA commercial API team overseeing Synthetic Molecule Active Pharmaceutical Ingredients (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 commercial API’s, ensuring compliance with applicable regulations.

Innovative Medicine Supply Chain Geel serves as Centre of Excellence for the development and manufacturing of 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.

As a QA Associate Commercial Synthetics, you are responsible for the quality oversight and timely release of an assigned product portfolio of commercial API’s, ensuring compliance with applicable regulations.

Within Johnson & Johnson, Innovative Medicine Supply Chain, we are recruiting a QA Associate commercial. This position is ideal for candidates with foundational experience in Quality Assurance who are eager to grow and contribute in a supportive role. You will be a member of our QA commercial API team overseeing Synthetic Molecule Active Pharmaceutical Ingredients (Synthetics) based in Geel, Belgium. You will work closely with the team to support the quality oversight of production plants and assist in the release of commercial API’s, ensuring compliance with applicable regulations.

Innovative Medicine Supply Chain Geel serves as Centre of Excellence for the development and manufacturing of 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 QA Associate commercial who is responsible to:

• Build and sustain strong partnerships with Business and Quality stakeholders to ensure alignment of objectives and results. Support and assist in building effective working relationships with Business and Quality stakeholders to help align objectives.

• Promote and strengthen the quality culture by providing coaching and training on cGMP requirements. Contribute to a quality culture by learning and sharing knowledge of cGMP requirements with team members.

• Have Quality oversight of commercial API’s manufactured at the Supply Chain site in Geel. Assist with Quality oversight activities for commercial API’s manufactured at the Supply Chain site in Geel.

• Work as one team with QA and Supply Chain partners ensuring timely release in support of a reliable supply chain. Collaborate with QA and Supply Chain partners to support timely release and reliable supply chain operations.

• 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. Support investigations of non-conformances, CAPAs, Change Controls, and Product Quality Complaints by assisting with documentation and compliance activities.

• Ensure that non-conformances and complaints with potential impact on patient safety and/or product supply are appropriately addressed and escalated. Help monitor and escalate non-conformances and complaints that may impact patient safety or product supply as needed.

• Review and approve Annual Product Review (APR) and Continued Process Verification (CPV) reports for the assigned product portfolio of commercial API’s. Assist in the preparation and review of Annual Product Review (APR) and Continued Process Verification (CPV) reports for assigned products under supervision.

• Review and approve GMP documentation such as procedures, work instructions, protocols and reports. Support the review and documentation of GMP procedures, work instructions, protocols, and reports as part of the QA team.

• Serve as Subject Matter Expert for assigned Quality Processes. Develop expertise in assigned Quality Processes and provide support to the team.

• Act as spokesperson during Health Authority inspections and customer audits. Participate in Health Authority inspections and customer audits by supporting the QA team and learning from experienced colleagues.

You will also provide quality support to the production plants.

We are looking for a QA Associate Commercial who is responsible to:

• 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.

• Have Quality oversight of commercial API’s manufactured at the Supply Chain site in Geel.

• Work as one team with QA and Supply Chain partners ensuring timely release in support of a reliable supply chain.

• 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.

• Review and approve Annual Product Review (APR) and Continued Process Verification (CPV) reports for the assigned product portfolio of commercial API’s.

• Review and approve GMP documentation such as procedures, work instructions, protocols and reports.

• Serve as Subject Matter Expert for assigned Quality Processes.

• Act as spokesperson during Health Authority inspections and customer 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.

• Take part in the standby / on-call rotation outside regular office hours (evenings and weekends) to support 24/7 manufacturing operations and ensure timely quality decision-making during continuous production.

We would love to hear from YOU, if you have the following essential requirements:

• 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.

• Demonstrated ability to work independently while staying connected with key stakeholders.

• 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.

• Strong analytical thinking skills and able to work in a flexible way under time pressure.

• Ability to make risk‑based decisions in a timely manner and understand the business implications of quality‑related decisions.

• In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.

• Experience with Quality Systems.

• Experience with regulatory inspections and preparedness.

• Fluent in Dutch and English, both spoken and written.

• Strong team player

Are you ready to make an impact?

If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.

Required Skills:

Preferred Skills: