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Quality Assurance and Operations Supervisor
Job summary
A leading recruitment firm is seeking a QA Operations Manager for a permanent role based in Madrid, Barcelona, Sofia or Lisbon. The successful candidate will oversee CDMO operations to ensure compliance with GMP and regulatory standards, conduct quality audits, and manage Quality Agreements. Applicants should possess a minimum of 5 years' experience in quality assurance, and excellent communication skills in English. This role is essential for maintaining regulatory inspection readiness and fostering a strong quality culture.
Qualifications
- Minimum 5 years in quality assurance.
- Experience in OSD or generics.
- GMP pharmaceutical experience.
Responsibilities
- Provide oversight of CDMO/service provider operations.
- Conduct quality audits and ensure implementation of CAPA plans.
- Review and approve quality and technical documentation.
Skills
Education
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.