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QA Manager (GMP/GDP)

CR/156123_1712934365
  • Negotiable
  • Allschwil, Basel-Country
  • Contract

A leading organisation in the Swiss pharmaceutical industry is looking for a QA Manager (GDP/GMP) to join their Global Pharmaceutical Development and Quality Assurance team.

Based in Allschwil, this is a full-time position on a 12-month contract which offers a unique chance to play a key role in the development and commercialisation of innovative pharmaceutical products.

The successful candidate will be part of a team dedicated to maintaining high-quality standards in medicine, significantly impacting global health.

Your Role as QA Manager (GDP/GMP)

In this role, you will:

  • Lead GMP/GDP quality assurance throughout product development and commercialisation, ensuring compliance with high-quality standards.
  • Manage quality activities across the product life cycle, applying six sigma methods for risk management.
  • Provide guidance on quality-related issues, including handling complaints, managing deviations, and implementing CAPA.
  • Oversee the release process for active ingredients and products, including documentation review and change control.
  • Represent the quality assurance department in cross-functional team meetings.
  • Conduct and assist in GMP/GDP audits at Contract Manufacturing Organisations (CMOs) and prepare quality agreements.
  • Write, review, and approve internal SOPs and other relevant documentation, contributing to the improvement of quality systems.
  • Propose enhancements to the quality system through new procedures or modifications.

Experience and Qualifications for the QA Manager Role

The ideal candidate should have:

  • A Master's degree in Pharmacy, Chemistry, or a related technical/science field.
  • 3-6 years of experience in various roles within pharmaceutical product development, quality control, or similar operational positions.
  • Experience in quality assurance of drug substances and/or products.
  • A thorough understanding of drug development, manufacturing processes, and quality control.
  • Strong knowledge of (c)GMP/GDP standards and the ability to effectively implement these standards.
  • Excellent project management skills with the ability to prioritise important tasks.
  • Strong interpersonal skills, with effective communication and the ability to influence.
  • Fluency in English and proficiency in an additional European language, ideally German or French.

Interested candidates are encouraged to apply immediately for consideration. For similar opportunities in the life sciences sector, please get in touch.

Isobel Abernethy Associate Consultant, Quality Assurance

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