QA Manager (optionally combined with QP role)This role coordinates and oversees all Quality activities, including QA oversight of QC testing for investigational medicinal products (IMPs), outsourced manufacturing and QC activities, and the implementation and maintenance of a GMP-compliant Quality Management System (QMS). The position will also support preparation for a GMP license application for QC testing of commercial products.Key ResponsibilitiesLeadership & Quality OversightLead the QA team: allocate resources, set priorities, plan work, develop training plans, and evaluate performance.Ensure implementation and maintenance of a compliant QMS.Ensure all activities comply with cGMP, internal procedures, Product Specification Files, and Quality Agreements.Maintain a culture of continuous improvement and ensure alignment with the parent company’s Quality strategy.Cross-Functional CollaborationCollaborate with QC, Project Leaders, CMC Director, and Process & Product Development teams.Participate in cross-departmental meetings and contribute to organizational improvements.Compliance, Audits & InspectionsManage vendor qualification and internal/external audit programs.Host regulatory inspections and client audits, ensuring CAPAs are implemented.Organize and lead the annual Quality Management Review, including KPI monitoring and improvement initiatives.Support Pre-Approval Inspection (PAI) readiness activities.QC Laboratory OversightDraft, review, and approve QMS procedures and policies.Approve QC methods, specifications, validations, protocols, reports, and Certificates of Analysis.Review and approve deviations, change controls, CAPAs, OOX investigations, equipment qualifications, and computerized system validations.Outsourced Manufacturing & QCOversee QA activities at CDMOs, including manufacturing and QC of IMPs.Ensure qualification and auditing of GMP vendors.Develop and approve Quality-Technical Agreements (QTAs).Review and approve tech transfer documents, master batch records, executed batch records, specifications, and investigations.Qualified Person Responsibilities (Optional)Perform duties under EudraLex Volume 4, Annex 16, including QP confirmation of IMPs for clinical trials in accordance with Regulation (EU) 536/2014.Education & ExperienceMaster’s degree in Pharmaceutical Sciences, Bioengineering, Biomedical Sciences, or related field (or equivalent experience).10–15 years of QA experience in GMP pharma/biotech environments, ideally in late-stage clinical development.At least 5 years overseeing outsourced manufacturing and QC activities (preferably biologics).Minimum 5 years of people management experience.Strong knowledge of cGMP (EudraLex Vol. 4), EP/USP, ICH/WHO guidelines, and US FDA regulations (21 CFR Parts 11, 210, 211).Experience with PPQ and BLA submissions is advantageous.Experience with regulatory inspections (e.g., FDA, EMA) preferred.SkillsStrong leadership, communication, planning, and organizational skills.Fluent in English; Dutch, Spanish, or Portuguese is a plus.Detail-oriented, pragmatic, and solution-focused with the ability to lead and develop teams in a fast-paced environment.