Senior QA Leader & Qualified Person (EU QP)

Wuxi Apptec, Inc.

Normandie

On-site

EUR 90,000 - 130,000

Full time

7 days ago
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Job summary

Wuxi Apptec, Inc. in France seeks a Senior Manager Quality Assurance / Qualified Person (QP) to ensure EU GMP and GDP compliance and oversee batch certification and release activities.

The role serves as a Qualified Person under Article 51 and supports regulatory inspections and audits while maintaining continuous inspection readiness. The candidate should hold a MSc in Life Sciences, be a QP in the Netherlands or eligible to act under EU/Dutch rules, and exhibit strong QA management,

Qualifications

  • Requires MSc in pharmacy, Pharmaceutical Sciences, chemistry, biology, biotechnology, or related Life Sciences.
  • Strong QA leadership and regulatory knowledge in GMP/GDP.
  • Excellent communication and documentation skills.

Responsibilities

  • Serve as local QA lead ensuring compliance with GMP/GDP and EU/Dutch requirements.
  • Maintain and improve the QMS in collaboration with QA leadership.
  • Act as registered Qualified Person and perform batch certification and release as applicable.

Skills

Organizational skills
Communication
Stakeholder management
Technical documentation

Education

Master’s degree in Life Sciences or related field

Tools

Microsoft Office

Job description

Wuxi Apptec, Inc. in France seeks a Senior Manager Quality Assurance / Qualified Person (QP) to ensure EU GMP and GDP compliance and oversee batch certification and release activities.

The role serves as a Qualified Person under Article 51 and supports regulatory inspections and audits while maintaining continuous inspection readiness. The candidate should hold a MSc in Life Sciences, be a QP in the Netherlands or eligible to act under EU/Dutch rules, and exhibit strong QA management,

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