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GMP Quality Systems Specialist
GMP Quality Systems, LEAN, Auditing, Compliance
Job
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.For our client Johnson & Johnson Innovative Medicine we are searching for a GMP Quality Systems Specialist.
Keywords
- GMP Quality Systems
- LEAN
- Auditing
- Compliance
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You will maintain and develop quality system procedures, ensure consistency across departments, and translate GMP, Janssen, and J&J requirements into practical and effective systems. A key part of the role is preparing JBV for regulatory inspections, performing internal audits, identifying areas for improvement, and driving the resulting compliance initiatives. You will apply tools such as Lean, Process Excellence, and Risk Management to assess and optimize the current state of quality processes.
As a specialist, you provide guidance to operational teams, support the rollout of quality initiatives, and develop GMP training programs to reinforce the right competencies across the organization. You also serve as a primary contact for quality system topics—internally within JBV and externally with JSC, J&J, regulatory agencies, and third parties. Maintaining strong communication channels and ensuring management is well‑informed are essential parts of the role.
Experienced specialists additionally act as key points of contact during inspections, advise leadership on major quality system topics, and manage GMP improvement projects end-to-end, including planning, quality, budget, and communications.
This position operates in a complex, multi-site, and multi-functional environment, requiring strong analytical skills, independence, and sound decision-making. You will interact with numerous stakeholders (internally and externally) and must be able to negotiate solutions, manage conflicting interests, and communicate with tact and diplomacy. Up-to-date knowledge of GMP and quality system trends is crucial to perform effectively in this role.
Profile
The ideal candidate holds a Master’s degree in a relevant scientific field and has 8–10 years of pharmaceutical industry experience, supported by additional professional training acquired throughout your career. You bring extensive knowledge of Quality Systems within a GMP environment and preferably have completed advanced courses in areas such as Process Excellence/Lean, Risk Management, and auditing.You are analytical, pragmatic, and experienced in working across complex, multinational organizations. With proven leadership and excellent communication skills, you can guide teams, advise stakeholders, and deliver clear, high-quality reports in English (Dutch is a plus).
Benefits
Contract for at least one year.Days of leave: 36
See here our other employment terms for this vacancy
Company profile
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.
They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.
