Overview
We are seeking an experienced Qualification & Validation Team Lead to lead and oversee GMP qualification and validation activities in line with EU GMP Annex 11 and Annex 15. This role is critical in ensuring compliant validation strategies across equipment, facilities, utilities, and computerised systems within a regulated pharmaceutical/biotech environment.
The successful candidate will provide technical leadership, manage validation teams and external vendors, and act as a subject matter expert (SME) for regulatory inspections and audits.
Key Responsibilities:
Leadership & Strategy
- Lead and mentor the Qualification & Validation team, ensuring high technical and compliance standards.
- Define and implement validation master plans (VMP) aligned with Annex 11 and Annex 15 requirements.
- Act as SME during regulatory inspections (EMA, FDA, MHRA) and internal audits.
Qualification & Validation Execution
- Oversee DQ, IQ, OQ, PQ activities for facilities, utilities, and manufacturing equipment.
- Ensure lifecycle-based validation approaches are applied and maintained.
- Review and approve qualification and validation documentation, protocols, and reports.
Computerised Systems & Data Integrity
- Ensure computerized systems are validated in compliance with Annex 11, GAMP 5, and data integrity principles.
- Oversee risk assessments, user requirement specifications (URS), and system lifecycle documentation.
Compliance & Continuous Improvement
- Ensure validation activities comply with EU GMP, Annex 11, Annex 15, and applicable global regulations.
- Identify and implement process improvements to enhance validation efficiency and compliance.
- Support change control, deviation management, and CAPA related to validation activities.
Cross-Functional Collaboration
- Work closely with Engineering, Quality Assurance, IT, Manufacturing, and Regulatory Affairs.
- Manage and coordinate external contractors and validation service providers.
Requirements:
- 5+ years of hands-on experience in GMP qualification and validation within pharma or biotech.
- Proven leadership experience managing validation teams or projects.
- Strong expertise in EU GMP Annex 11 and Annex 15.
- Deep knowledge of equipment, facility, utility, and process qualification.
- Strong understanding of CSV, GAMP 5, and data integrity requirements.
- Experience with risk-based validation approaches.
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