Quality Assurance Operations Manager

BioTalent; Madrid; Híbrido; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading recruitment agency is seeking a QA operations manager for a permanent position based in either Barcelona, Sofia, or Lisbon. The role involves providing oversight of operations to ensure compliance, conducting quality audits, and reviewing technical documentation. Candidates must have a minimum of 5 years in quality assurance, communication skills in English, and GMP pharmaceutical experience. This position offers a chance to negotiate Quality Agreements and promote a strong quality culture within the organization.

Formación

• Minimum 5 years in quality assurance.
• QP qualification is a bonus.
• OSD or generics experience required.
• GMP pharmaceutical experience necessary.

Responsabilidades

• Provide oversight of CDMO operations for regulatory compliance.
• Conduct quality audits and implement CAPA plans.
• Review and approve quality and technical documentation.
• Continuously assess processes for quality improvements.
• Negotiate and manage Quality Agreements.
• Support regulatory inspection readiness activities.
• Participate in due diligence assessments.
• Monitor Quality Management System performance.
• Deliver GMP / GDP training and promote quality culture.
• Collaborate with global teams on Quality Assurance activities.

Conocimientos

Quality assurance experience

Excellent communication skills in English

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.