Associate Director, Qualified Person, Europe

The Opportunity:

The Qualified Person (QP) holds ultimate responsibility for the certification and release of medicinal products in accordance with EU GMP, Directive 2001/83/EC, Dutch pharmaceutical legislation, and applicable Marketing Authorisations.

The role provides independent, authoritative quality leadership across site operations and serves as a key member of the site leadership team, ensuring patient safety, product quality, regulatory compliance, and reliable supply.

In addition to batch release accountability, the QP provides strategic oversight of the Pharmaceutical Quality System, partners closely with senior stakeholders across Quality, Technical Operations, Supply Chain, and Regulatory Affairs, and represents the site in interactions with Health Authorities.

• Regulatory Accountability & Product Release

  • Act as the legally registered Qualified Person with full authority for certification and release of clinical and commercial medicinal products.

  • Ensure batch certification in compliance with EU GMP, Directive 2001/83/EC, national legislation, EU GMP Annex 16, the applicable Marketing Authorisation, and approved regulatory dossiers (e.g., MA, IMPD), and applicable authorisations.

  • Exercise independent decision-making authority, including batch rejection and escalation when required.

  • Ensure timely batch disposition aligned with supply commitments and compliance requirements.

  • Responsible for the certification and release of Investigational Medicinal Products (IMPs) in accordance with EU Clinical Trial Regulation and EU GMP Annex 13, including oversight of randomisation, blinding, labelling, comparators, and clinical supply chain integrity.

  • Maintain QP oversight of the end‑to‑end GMP supply chain, including qualification, approval, and ongoing monitoring of contract manufacturers, testing laboratories, API suppliers, and logistics providers.

• Quality System Leadership

  • Provide oversight of the Pharmaceutical Quality System, ensuring inspection readiness and regulatory alignment.

  • Oversee deviations, CAPAs, change controls, investigations, complaints, and recalls.

  • Approve critical GMP documentation including SOPs, validation documentation, and quality agreements.

  • Ensure that third‑country manufacturing sites comply with EU GMP requirements, including audit strategy, GMP equivalence assessment, and importation controls.

  • Provide QP oversight of data integrity governance across GMP processes and computerized systems, ensuring adherence to ALCOA+ principles, validated system use, appropriate audit trails, and timely escalation of data integrity risks that may impact batch certification or regulatory complian

  • Oversee continued process and product verification activities, including stability programs, ongoing trend analysis, and Product Quality Reviews (PQR/APQR), ensuring that emerging quality risks are identified, assessed, and managed proactively throughout the product lifecycle.

• Strategic & Cross-Functional Leadership

  • Act as a strategic quality partner to site and functional leadership.

  • Lead quality risk assessments related to manufacturing operations and change initiatives.

  • Mentor QA professionals and support QP succession and capability building.

  • Embed a proactive quality culture across the organization.

• Regulatory & External Representation

  • Serve as primary QP representative during inspections and Health Authority interactions.

  • Lead inspection readiness and coordinate regulatory responses.

  • Maintain oversight of recall activities.

• Performance, Governance & Escalation

  • Define and present quality KPIs, trends, and risk assessments to senior management.

  • Drive continuous improvement using data-driven insights and benchmarking.

  • Provide escalation support during critical quality events.

  • Act independently in the execution of QP duties, maintain direct access to senior management for escalation of critical quality, compliance, or patient safety risks, and ensure that QP certification decisions are not compromised by commercial or supply pressure.

  • Maintain an effective interface with Pharmacovigilance to ensure timely assessment and escalation of quality‑related safety signals, quality defects, recalls, and Rapid Alerts, in accordance with regulatory expectations and patient safety requirements.

Required Skills, Experience and Education:

• Master's degree in Pharmacy, Chemistry, Biotechnology, or relevant scientific discipline.

• 9+ years experience working in quality related roles with increasing responsibility.

• Eligibility for registration as a Qualified Person under Dutch pharmaceutical legislation.

• Extensive experience as a Qualified Person with direct batch release accountability.

• Deep working knowledge of EU GMP and relevant regulatory frameworks.

• Proven inspection experience and senior stakeholder engagement capability.

• Fluency in English; Dutch language skills are an advantage.

• Risk-based, pragmatic mindset balancing compliance and supply reliability.

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