Quality Assurance Operations Manager

BioTalent; Barcelona; Híbrido; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

A leading recruitment agency is seeking a QA Operations Manager to oversee compliance and quality assurance operations. This position, based in Barcelona, Sofia, or Lisbon, requires at least 5 years in quality assurance, with a preference for candidates with GMP pharmaceutical experience. Responsibilities include conducting audits, reviewing documentation, and ensuring quality systems performance. Excellent communication skills in English are necessary for this role, which plays a pivotal part in maintaining a strong quality culture and supporting regulatory activities.

Formación

• Minimum 5 years in quality assurance.
• Excellent communication skills in English.
• Experience in OSD or generics.

Responsabilidades

• Provide oversight of CDMO/service provider operations.
• Conduct quality audits of Suppliers/CDMOs.
• Review and approve quality and technical documentation.
• Monitor and report on Quality Management System performance.

Conocimientos

Quality Assurance

Communication skills

GMP experience

Risk Assessment

Educación

Quality Assurance Qualification (QP)

Descripción del empleo

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.