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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. Para presentar una candidatura, simplemente lea la siguiente descripción del puesto y asegúrese de adjuntar los documentos pertinentes.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. xohynlm 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.
