QA Manager – External Quality (CMOs) – Europe (Remote)

BioTalent is partnered with a global pharmaceutical leader to support the hire of a Quality Assurance Manager with strong experience in GMP compliance, third-party manufacturing oversight, and pharmaceutical quality systems.

This role will offer you:

• A chance to join a fast-paced, international team with a strong quality-driven culture
• Ownership of QA activities across a wide network of CDMOs, API suppliers, and service providers
• The opportunity to influence quality strategy and drive continuous improvement

Key Responsibilities:

• Conduct audits and ensure CAPA implementation across third-party sites
• Manage and negotiate Quality Agreements with suppliers and manufacturing partners
• Provide GMP training and support for regulatory inspections (EMA, FDA, ANVISA, etc.)
• Review and approve critical quality documentation across development and tech transfers
• Oversee GMP/GDP compliance at CDMOs and contribute to due diligence assessments
• Monitor QMS performance, support risk assessments, and collaborate with global teams

Key Requirements:

• Degree in Pharmacy, Chemistry, or a related science
• Extensive experience in pharmaceutical QA or manufacturing
• Strong working knowledge of EU GMP, GDP, and global regulatory standards
• Experience with oral and injectable dosage forms and regulatory inspections
• Confident auditing and communication skills, with fluency in English