Director of C&Q

EU-Based Biologics Manufacturing LeaderSite-Based Position | EU Work Authorisation RequiredAre you an experienced CQV leader with a strong background in biologics manufacturing and large-scale GMP operations? We are partnering with a leading European biologics organisation that develops and manufactures complex biologic medicines for patients around the world. With significant investment in manufacturing expansion, advanced technologies, and operational excellence, the company offers a unique opportunity to lead a critical function at one of Europe's most advanced biologics manufacturing sites. This is a highly visible leadership role, combining strategic oversight, technical expertise, and people leadership within a fast-growing and innovative biotech environment. The RoleAs Head of Commissioning & Qualification (CQV), you will be responsible for leading all site-wide commissioning, qualification, and validation activities across manufacturing, utilities, facilities, automation, and computerized systems. Leading a team alongside external project resources when required, you will ensure all systems remain in a compliant qualified state while supporting major capital projects, manufacturing expansion initiatives, and ongoing operational excellence programmes. Key ResponsibilitiesDevelop and lead the site-wide Commissioning & Qualification strategy, ensuring alignment with business objectives, regulatory requirements, and long-term manufacturing plans.Provide technical and strategic leadership for all commissioning, qualification, validation, and lifecycle management activities across manufacturing facilities, utilities, laboratories, automation platforms, and computerized systems.Act as the site Subject Matter Expert (SME) for C&Q, establishing risk-based qualification frameworks and ensuring consistent application of GMP and industry best practices.Lead qualification activities for major capital projects, facility expansions, technology transfer programmes, and new manufacturing assets, ensuring smooth delivery from design through operational handover.Oversee commissioning and qualification of critical GMP systems including Drug Substance and Drug Product equipment, single-use bioreactors, downstream processing equipment, fill-finish systems, clean utilities, HVAC systems, cleanrooms, laboratory equipment, and automation platforms.Ensure successful execution and approval of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), while supporting process validation activities across the site.Maintain inspection readiness and ensure compliance with EU GMP Annex 15, FDA requirements, EudraLex, GAMP 5, ASTM E2500, and other applicable regulatory standards, while supporting audits and regulatory inspections.Build, mentor, and develop a high-performing CQV organisation, managing internal teams and external partners while driving operational excellence, continuous improvement, and programme delivery against schedule and budget commitments. Eligibility10+ years of Commissioning, Qualification and Validation experience within pharmaceutical, biotechnology, biologics, or advanced therapy manufacturing environments.Proven leadership experience managing technical teams, managers, and cross-functional stakeholders.Strong expertise across equipment, facilities, utilities, automation, and computerized systems qualification.Experience within biologics manufacturing environments is strongly preferred.Knowledge of Drug Substance (DS) and Drug Product (DP) manufacturing operations.Experience supporting regulatory inspections and defending qualification strategies during audits.Excellent communication and stakeholder management skills with the ability to influence across Engineering, Manufacturing, Quality, MSAT, and Regulatory functions.Engineering degree preferred, ideally Mechanical, Process, Chemical, or similar discipline. Highly Desirable ExperienceSingle-use bioreactorsUpstream and downstream processing systemsFill-finish manufacturingSterilisation systems and autoclavesComputerised Systems Validation (CSV)Automation systems qualificationClean utilities, HVAC, and cleanroom validationDigitalisation, AI, or data-driven validation approaches Why Join?Opportunity to lead a critical site function within a rapidly growing biologics manufacturer.Significant influence over future expansion projects and capital investment programmes.Manage a diverse portfolio of manufacturing, engineering, automation, and validation activities.Be part of an organisation that combines the quality standards of global pharmaceutical companies with the agility and pace of an innovative biotech business.Lead the development of long-term in-house CQV capability rather than relying heavily on external consultancy support. Eligibility: Candidates must hold valid EU work authorisation and be able to work on-site.Location: EU-Based Manufacturing Site (On-Site Position) For a confidential discussion, please get in touch: [email protected]