Quality Assurance Specialist – External Manufacturing (CMO)

About the role

We are seeking a Quality Assurance Specialist to oversee external manufacturing activities for a leading pharmaceutical partner. The role focuses on ensuring GMP compliance across contract manufacturers and supporting batch release, change control, and complaint handling.

Key responsibilities

• Manage quality activities related to Contract Manufacturing Organizations (CMOs) and ensure GMP compliance at every stage.
• Review, track, and resolve deviations raised by CMOs, driving timely corrective actions.
• Monitor and validate closure of CAPAs in line with regulatory expectations.
• Approve change controls submitted by external manufacturing partners.
• Support drug product batch release activities, ensuring full regulatory compliance.
• Review and approve product market complaints, contributing to pharmacovigilance and continuous improvement.
• Act as a key interface between internal QA/operations teams and external partners within a matrix organization.

Required profile

• University degree in a scientific discipline (e.g., bio‑engineering, biology, biotechnology, pharmacology, chemistry).
• Minimum 5 years of experience in a cGMP‑regulated pharmaceutical environment.
• Strong knowledge of Good Manufacturing Practices and relevant regulatory frameworks.
• Fluent in English, both written and spoken.
• Proven analytical thinking, pragmatic mindset, and problem‑solving abilities.
• Excellent communication and stakeholder‑management skills in a matrix setting.

Required skills

• SAP
• Veeva quality management system

What we offer

• Long‑term assignments with leading pharmaceutical players.
• Continuous learning through technical coaching, training, and knowledge sharing.
• Supportive culture that values autonomy, trust, and impact.
• Attractive salary package with additional benefits.