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Quality Assurance Manager - Operations
Job summary
A leading recruitment agency is searching for a QA Operations Manager to oversee compliance and quality assurance in the pharmaceutical industry. The ideal candidate should have at least five years of experience in quality assurance, with GMP knowledge being essential. This role can be based in Barcelona, Sofia, or Lisbon, and involves conducting audits and managing quality agreements with suppliers. Excellent communication skills in English are required for this position.
Qualifications
- Minimum 5 years in quality assurance.
- QP qualification is a bonus.
- OSD or generics experience required.
Responsibilities
- Provide oversight of CDMO/service provider operations.
- Conduct quality audits of Suppliers/CDMOs.
- Review and approve quality and technical documentation.
Skills
A key client of BioTalent are looking for a QA operations manager on a permanent basis. This candidate can be based in either Barcelona (Spain), Sofia (Bulgaria) or Lisbon (Portugal). Candidates based outside of cannot commute to such locations will not be considered.
- Provide oversight of CDMO / service provider operations to ensure ongoing GMP / GDP and regulatory compliance.
- Conduct quality audits of Suppliers / CDMOs and ensure implementation of CAPA plans.
- Review and approve extensive quality and technical documentation, including specifications, batch records, validation documents, and risk assessments.
- Continuously assess CDMO / service provider processes and recommend quality and operational improvements.
- Negotiate and manage Quality Agreements with Suppliers, CDMOs, and other third parties.
- Support regulatory inspection readiness activities for Suppliers / CDMOs.
- Participate in due diligence assessments for new product dossiers and potential partners.
- Monitor and report on Quality Management System performance and support quality risk assessments.
- Deliver GMP / GDP training, coaching, and promote a strong quality culture internally and externally.
- Collaborate with global teams and support budget management and broader Quality Assurance activities as needed.
- Minimum 5 years in quality assurance
- QP qualification is a bonus
- OSD or generics experience
- Excellent communication skills in English
- GMP pharmaceutical experience
Reach out for further information.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.