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.
Responsibilities:
* 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.
Qualifications:
* 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.