QA Manager

BioTalent Ltd; Paris; Hybride; EUR 60 000 - 100 000; Plein temps

Résumé du poste

BioTalent is partnering with a global pharmaceutical leader to find a Quality Assurance Manager experienced in GMP compliance and quality systems. This remote role entails ownership of QA activities across a network of suppliers and offers the ability to influence quality strategies while working in a dynamic, international team.

Qualifications

• Extensive experience in pharmaceutical QA or manufacturing.
• Strong knowledge of EU GMP and global regulatory standards.
• Experience with oral and injectable dosage forms.

Responsabilités

• Conduct audits and ensure CAPA implementation.
• Manage Quality Agreements with suppliers and partners.
• Provide GMP training and support for inspections.

Connaissances

GMP Compliance

Pharmaceutical Quality Systems

Auditing Skills

Negotiation Skills

Communication Skills

Formation

Degree in Pharmacy

Degree in Chemistry

Description du poste

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

BioTalent is partnered with a global pharmaceutical leader to support the hire of aQuality Assurance Managerwith 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