Pilot Plant Quality and Compliance Lead

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.

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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 $94.2 billion in 2025 sales Johnson & Johnson is the worlds most comprehensive and broadly-based manufacturer of pharmaceuticals and medical devices. The Johnson & Johnson Innovative Medicines conducts research and development in a variety of therapeutic areas to discover novel therapeutic approaches to address unmet medical conditions driven by strong science and innovation.

The Chemical Process Research and Development (CPRD) departmentis seeking a Pilot Plant Quality and Compliance Lead to join our team inBelgium. CPRD has three state of the art chemical pilot plants in Beerse and Geel which support the development of new chemical processes and produce Active Pharmaceutical Ingredients (APIs) used in clinical trials. The Chemical Development Pilot Plant (CDPP) in Geel also supports the launch of new small volume commercial products. The pilot plants are constantly innovating their technology- and data infrastructure to accommodate for future products and they operate according to phase appropriate cGMPs . As an expert the Quality and Compliance lead is responsible for the implementation of the phase appropriate quality& compliance standards in the pilot plants with a focus on work-processes process-equipment computer systems data integrity and building &facilities. As member of the pilot plant staff the lead works closely together with the Quality Assurance Organization and the site systems owners network to be sure the pilot plants are inspection ready. For this purpose the Quality and Compliance Lead organizes and supports risk-assessments gap-analyses and live cycle management to be sure an adequate quality system is set up for clinical the environment of constantly evolving regulatory requirements the pilot plant quality and compliance lead is also responsible to define a risk based approach consistent with the current stage of drug development and product knowledge.

The Johnson & Johnson campus in Belgium hosts 5000 employees and has a unique ecosystem covering the complete drug development life cycle with all capabilities from basic science to market access on one campus. The integrated environment of our campus gives our people the chance to experience many different aspects of drug development throughout their career. It has a successful track record of over sixty years of drug discovery and development and it is one of the most important innovation engines of the Johnson &Johnson group worldwide.

Qualifications

Experience and Skills

• Ph. D. or Master in Chemistry or Chemical Engineering with 5-10 years of experience in the Pharmaceutical Industry.
• Practical knowledge of cGMP and Q7A.

• Strong team player with previous experience in leading teams.
• Understanding of process safety operations process development & engineering

• Hands-on experience in pilot or large-scale manufacturing plants
• Challenge the status quo and analytical mindset
• Project management skills

Your Activities

• Defines what phase appropriate c-GMPs means for the API pilot plants in an evolving landscape and how CDS can implement these requirements retaining the flexibility and speed for development activities.
• Initiating and implementation of projects to keep the compliance level of CDS systems at the evolving and required standards. Systems in scope are equipment and systems qualification data integrity contamination control system based compliance .
• Function is the spokesperson towards the QA organization and takes the lead in CDS to prepare audit readiness of the plant.
• Function has to install a live cycle management program to keep our systems in accordance with the actual regulations.
• Is SME in GMP requirements for API production and gives guidance to the team

Our Offer:

• An exciting position in an international and dynamic environment with continuous learning and growth opportunities
• An attractive remuneration package withadditional benefit packages(for example hospital insurance and other health care incentives)
• An inclusive team environment where diversity and different opinions are respected and valued and the importance of a good work-life balance is recognized

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