Senior Quality Assurance Manager & Qualified Person

Wuxi Apptec, Inc.; Amsterdam; Presencial; EUR 120 000 - 150 000; Tempo integral

Resumo da oferta

Wuxi Apptec, Inc. in Amsterdam, Netherlands, seeks a Senior Manager Quality Assurance / Qualified Person (QP) to ensure that medicinal products are manufactured, tested, released and distributed in full compliance with EU GMP/GDP and Dutch regulations.

The role leads QA activities, maintains the QMS, and serves as the registered QP, overseeing batch certification and release where delegated. Strong experience in GMP quality systems and regulatory inspections is essential.

Qualificações

• Master's degree in pharmacy or life sciences.
• Qualified Person (QP) status in NL or eligible under EU/Dutch rules.
• 5+ years of pharmaceutical QA experience in GMP environment.
• Experience with deviations, CAPA, change control, risk management, documentation.

Responsabilidades

• Serve as the local Quality Assurance lead, ensuring GMP, GDP, EU and local regulatory requirements, and company quality standards.
• Maintain and continuously improve the Quality Management System (QMS) in collaboration with the Director QA EMEA.
• Act as a registered Qualified Person and perform batch certification and release activities (where delegated).
• Ensure the quality and regulatory compliance of imported medicinal products and investigational medicinal products, including review of batch documentation.
• Manage key quality processes, including deviations, CAPAs, change controls, complaints, supplier quality, quality agreements, and document management.
• Qualify and oversee suppliers, manufacturers and contractors, ensuring effective quality oversight of external partners and supply chains.
• Prepare for and support regulatory inspections, customer audits, and supplier audits, maintaining continuous inspection readiness.
• Investigate quality events, implement effective CAPAs, monitor quality metrics, and drive continuous improvement and a culture of quality and compliance.
• Provide QA guidance and support to internal stakeholders and external partners, escalating critical quality and compliance issues where appropriate.

Conhecimentos

Quality Assurance

Regulatory Compliance

Stakeholder Management

Documentation

GMP

Auditing

Project Management

English fluency

Formação académica

Master's degree in Pharmacy

Qualified Person (QP) status – NL

Ferramentas

MS Office

Descrição da oferta de emprego

Wuxi Apptec, Inc. in Amsterdam, Netherlands, seeks a Senior Manager Quality Assurance / Qualified Person (QP) to ensure that medicinal products are manufactured, tested, released and distributed in full compliance with EU GMP/GDP and Dutch regulations.

The role leads QA activities, maintains the QMS, and serves as the registered QP, overseeing batch certification and release where delegated. Strong experience in GMP quality systems and regulatory inspections is essential.