Quality Manager
The Quality Manager is responsible for providing immediate quality leadership and operational support within a GMP-regulated sterile manufacturing environment. The role focuses primarily on Quality Assurance oversight of qualification and validation, material and supplier qualification, and maintenance and calibration systems.
Key Responsibilities:
Qualification and Validation Oversight:Provide QA oversight and hands-on support for qualification and validation activities, including:o Equipment qualificationo Utilities qualification (e.g. HVAC, gases)o Computerized systems validationReview and approve qualification and validation protocols, reports, and deviationsEnsure validation lifecycle principles are applied and maintainedSupport aseptic process validation activities from a QA perspectiveMaterial and Supplier QualificationEstablish, review, and maintain material qualification processes, including starting materials, primary packaging components, and consumablesEnsure suppliers are appropriately qualified and approved through risk-based assessments and audits (as applicable)Review and approve supplier-related changes, deviations, and quality notificationsSupport the maintenance of quality agreements with suppliers
Maintenance and Calibration Oversight:Provide QA oversight of maintenance and calibration systems for GMP-critical equipment and utilities.Review and approve maintenance and calibration plans, records, deviations, and change controls.Ensure calibration status is maintained and appropriately documented to support GMP compliance and data integrity.
Operational QA Support:Provide hands-on QA support to daily operations, including:o Deviation and investigation managemento Change control assessment and approvalo CAPA definition and effectiveness follow-upo Risk assessments related to equipment, utilities, and materialsSupport SOP updates and remediation activities related to qualification, validation, and technical systems.
Requirements for the Role:
University degree in a scientific or engineering discipline (e.g. Pharmacy, Chemistry, Engineering, Life Sciences).Minimum of 5–8 years of experience in Quality Assurance within a GMP-regulated pharmaceutical environment.Demonstrated experience supporting sterile manufacturingProven hands-on experience with equipment qualification, validation, and technical quality systems.Strong knowledge of EU GMP requirements, including Annex 1 and Annex 15.Practical understanding of qualification and validation lifecycle principles.Experience with supplier qualification and quality oversightSolid understanding of maintenance and calibration requirements in GMP environments.Clear, concise documentation and communication skills.Pragmatic, solution-oriented approach with sound quality judgment.Ability to work independently and integrate quickly into an existing organization.Demonstrates strong GMP awareness and attention to detail