Experienced Specialist QA

• Providing oversight for Advanced Therapies production activities at the site
• Providing quality guidance for GMP processes including Change Control, Document Control, GMP Training, and inspection readiness
• Providing quality guidance for facility, utility, and equipment design activities, including new facility projects
• Supporting technology transfers, analytical transfers, qualification programs, and validation activities
• Supporting aseptic processing operations and Annex 1 compliance requirements
• Reviewing and assessing Quality Investigations and monitoring the quality of root cause investigations
• Assessing non-conformances for potential impact on product quality or compliance status and supporting product disposition decisions
• Reviewing and approving appropriate Corrective and Preventive Actions (CAPAs)
• Escalating significant quality, compliance, or GMP issues and supporting local and global escalation activities where patient supply may be impacted
• Participating in hazard assessments and Quality Risk Management activities
• Coordinating, reviewing, and delivering GMP training activities related to investigations, qualifications, and non-conformance management
• Supporting quality culture initiatives across manufacturing and laboratory operations, including GEMBA activities
• Reviewing and approving document changes and change controls
• Leading or participating in local and global quality and capacity projects
• Enhancing process monitoring and quality monitoring approaches
• Acting as a Quality SME during inspection preparation activities and supporting FDA, EMA, and other regulatory inspections
• Supporting Annual Product Reviews (APR), inspection readiness reports, and related compliance activities
• Partnering with site colleagues to ensure changes to manufacturing processes, equipment, facilities, and systems are implemented in a controlled and compliant manner
• Participating in a rotating 24/7 on-call schedule as the QA representative for quality-related issues

As an Experienced Specialist, QA, you will also represent Quality in Advanced Therapies projects, support identification and mitigation of compliance risks, review and approve study protocols and reports, and participate in Quality Risk Management and root cause investigation sessions.

• Bachelor's degree or higher in Biochemistry, Biology, Pharmaceutical Sciences, or another relevant scientific field

• Minimum 6 years of experience in a GMP-regulated environment with a Bachelor's degree, or 4 years of experience with a Master's degree
• Experience within Quality Assurance, Quality Control, manufacturing operations, or related pharmaceutical or biotechnology environments
• Experience with methodologies such as Process Excellence, Co-Think, Kepner-Tregoe, or similar approaches is preferred
• Proven knowledge of the biotechnology and/or pharmaceutical industry

Technical Knowledge

• Strong understanding of global regulatory requirements, including cGMP, ICH, FDA, and EMA expectations
• Knowledge of Quality Systems including change control, deviation management, CAPA, validation, and risk management
• Understanding of manufacturing processes, laboratory operations, facilities, utilities, and technical automation systems
• Experience supporting investigations, troubleshooting activities, and development of compliant solutions to quality issues

Skills

• Ability to work independently and make risk-based decisions in a complex environment
• Strong analytical, problem-solving, and decision-making skills
• Ability to balance business needs, regulatory requirements, quality expectations, and patient impact
• Strong collaboration, influencing, and negotiation skills
• Ability to engage partners and navigate differing viewpoints effectively
• Strong communication skills, both written and verbal
• Fluent in English
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

We offer a collaborative environment where learning, innovation, and professional development are encouraged. This role provides opportunities to contribute to Advanced Therapies manufacturing, collaborate across multiple functions, and support products that can make a meaningful difference for patients.

Additional role information

• Location: Leiden/Sassenheim, The Netherlands
• Participation in a rotating 24/7 on-call schedule is required
• Close collaboration with Operations, QC, Warehouse, MAM, MSAT, and Quality functions is expected
• Support for regulatory inspections and audits may be required as part of normal responsibilities