Product Quality director

BioTalent have partnered with a rapidly growing, specialty pharmaceutical company focused on expanding access to high-value medicines across Europe and international markets. Operating within a strategic outsourced manufacturing and distribution model, they partner with leading CMOs and API suppliers to bring complex, innovative therapies to patients.

They are looking to onboard a Director of product quality on a permanent basis in the Netherlands-remote. This is a senior regulatory leadership role with formal responsibility as: EU Qualified Person (QP)

for batch certification Responsible Person (RP)

under EU Wholesale Distribution Authorisation (WDA) You will shape and own the end-to-end Product Quality strategy across manufacturing, API supply, importation, and distribution activities.

Key Responsibilities: Strategic Product Quality Leadership Design and evolve a scalable Product Quality strategy aligned with portfolio expansion Establish governance frameworks for outsourced CMOs and API suppliers Provide executive-level quality risk assessments and strategic input QP & Regulatory Accountability Perform EU batch certification and release activities Establish and maintain Manufacturer / Importer Authorisations (MIA) Act as primary contact during GMP and GDP inspections Ensure compliance with EU GMP (Parts I & II), GDP, and ICH requirements API & Manufacturing Oversight Lead supplier qualification, audit strategy, and CMO governance Approve manufacturing changes, deviations, investigations, and CAPAs Assess regulatory impact of CMC lifecycle changes Own and govern Technical & Quality Agreements Portfolio Expansion & Due Diligence Lead CMC and Product Quality due diligence for in-licensing and acquisitions Conduct formal go/no-go risk assessments for executive leadership Support integration of acquired products into the Quality framework Continuous Improvement & Risk Management Drive inspection readiness across the partner network Implement proactive Quality Risk Management (QRM) Build scalable, future-proof Product Quality systems

Eligibility: Registered

EU Qualified Person (QP) Eligible to act as EU QP and/or Responsible Person under Dutch MIA/WDA licences Extensive hands-on EU batch certification experience Strong experience in outsourced, multi-partner manufacturing models Deep expertise in EU GMP (Parts I & II), GDP, CMC lifecycle management, deviations & CAPA Proven Health Authority inspection leadership Experience in CMC due diligence for licensing/acquisitions highly desirable

Reach out for more information to: luisa.namadila@biotalent.com