Location: Leiden, Netherlands Department: Quality Assurance
ClinChoice is seeking a Quality Assurance Specialist to join a leading pharmaceutical company in the field of biomedicines. This is a hybrid role based in Leiden, 1.0 FTE, until July 2026.
As a global full-service CRO, ClinChoice offers a supportive culture focused on quality and professional development. This client-facing role requires confident individuals who can work independently and build strong relationships with client counterparts.
Scope of the Role:
Provide QA support to commercial/clinical production at the Leiden/Sassenheim AT manufacturing site. Serve as the primary point of contact for all AT quality-related topics, including production facilities and quality control labs. Offer quality oversight for the manufacture of Drug Substances/Starting Materials in AT. Deliver independent reviews and provide clear, pragmatic, and quality-driven advice on GMP compliance. Collaborate closely with Operations, QC, Warehouse, MAM, and MSAT departments. Report to the Manager QA AT and work alongside other QA specialists. Internal contacts include colleagues at operational and managerial levels across all site departments. External contacts include quality and non-quality representatives within IMSC companies.
Main Job Tasks and Responsibilities:
- Provide Quality oversight to the AT Production facility.
- Support GMP standards and provide Quality guidance for:
- All GMP processes (e.g., Change Control, Doc Control, GMP Training, inspection readiness).
- Facility, utility, and equipment design (e.g., new Pollux Facility).
- Technology and/or Analytical Transfer.
- Qualifications and Validations.
- Aseptic Processing and Annex 1 adherence.
- Assess and review Quality Investigations, support investigation teams, and monitor Root Cause investigations. Assess non-conformances for product quality or compliance impact and decide on product disposition.
- Provide Quality support for the development and approval of Corrective and Preventative Actions (CAPA).
- Escalate serious quality, compliance, and/or GMP incidents to Site or Global Management, supporting the escalation of issues impacting product delivery to patients.
- Participate in Hazard/Risk assessments to ensure compliance and quality.
- Coordinate, review, and provide GMP training (e.g., Non-conformances, Investigation techniques, Qualifications) to site colleagues.
- Drive initiatives to enhance quality and compliance culture, including GEMBA walks in manufacturing and laboratory areas.
- Review and approve document changes and change controls.
- Lead or participate in local or global capacity/quality projects.
- Optimize current and identify new methods for process and quality monitoring.
- Be available on a rotation basis 24/7 as a QA representative for quality issues.
- Act as a Quality Subject Matter Expert (SME) and participate in preparations for and during inspections (FDA, EMA, etc.).
- Partner with site colleagues to ensure all site changes (production processes, equipment, systems) are controlled, systematic, and compliant with cGMP and regulatory requirements.
- Lead and support the facility in identifying and eliminating compliance risks.
- Act as a quality representative and provide expertise for JBV projects to ensure cGMP and company quality requirements.
- Assess, review, and approve study protocols and reports (e.g., stability, validation, analytical technical transfer) to ensure execution in a controlled, systematic manner compliant with cGMP and regulatory requirements.
- Participate in Quality Risk Management and/or root cause investigation sessions.
Education and Experience:
- Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical Science, or a related field.
- Minimum of 6 years of experience for a BSc or 4 years for an MSc in a GMP-regulated environment (manufacturing, QA, and/or QC).
- Experience with methods such as Process Excellence, Co Think, or Kepner-Tregoe is recommended.
- Proven knowledge of the biotechnological/pharmaceutical industry.
- Proficiency in English (written and verbal).
- Deep understanding and application of Global Regulatory (cGMP/ICH/FDA/EMA) guidelines in an Operations environment.
- Ability to function independently in a complex environment, making daily judgments to balance business needs, regulatory requirements, and cost efficiency. Must be able to determine risk, magnitude, and complexity to make sound judgments on escalating critical issues.
- Broad knowledge of QA systems (change control, deviation management, cGMP, validation), manufacturing and laboratory processes, facilities, utilities, and technical automation.
- Strong problem-solving and troubleshooting skills to develop innovative and compliant solutions for quality issues.
- Ability to drive collaboration in a fast-paced environment.
- Good negotiation skills with a customer-oriented attitude. Ability to influence and engage colleagues and manage diverse and conflicting viewpoints.
- Empowered professional capable of making well-motivated, pragmatic decisions independently.
About ClinChoice:
ClinChoice is a global full-service CRO with over 28 years of experience, specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 4,000 professionals in more than 20 countries, we deliver high-quality results across all services.
Our Company Ethos:
Our mission is to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. We value our employees as our most important asset, focusing on close management and continuous training to maintain highly qualified personnel. Our commitment to training ensures our resources are competent and expert, equipped to manage internal and client processes with consistent methodology. This focus is reflected in our below-industry-average turnover rates.
ClinChoice is an equal opportunity employer committed to diversity and inclusivity. We attract, develop, and promote talent from diverse backgrounds, recognizing this as our strength.
