Senior Quality Control Lead

We’re supporting a leading global biopharmaceutical manufacturing organisation with the appointment of an experienced Quality Control professional to strengthen its Pre-Approval Inspection (PAI) readiness, analytical method transfer and QC compliance capabilities
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This is a highly visible role within a complex GMP manufacturing environment, working across Quality Control, Quality Assurance, Manufacturing Science and Technology (MSAT), Validation and Regulatory Affairs.

The successful individual will act as a senior technical and compliance Subject Matter Expert (SME), helping ensure laboratory operations are fully prepared for FDA and other global regulatory inspections.

• Lead and support FDA PAI and regulatory inspection readiness activities across QC laboratories.
• Act as a senior SME during FDA, EMA, PMDA and client inspections/audits
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• Provide technical leadership across analytical testing, including Drug Substance, In-Process Control and compendial testing
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• Lead and oversee analytical method transfer, qualification, verification and validation activities.
• Troubleshoot complex analytical and laboratory issues, leading root cause investigations and effective CAPA implementation.
• Assess QC laboratory systems against cGMP, ICH, Data Integrity and ALCOA+ expectations.
• Provide oversight across deviations, CAPAs, Change Controls, risk assessments and Data Integrity investigations.
• Serve as a key technical interface with pharmaceutical and biotechnology clients during method transfer and inspection-readiness programmes.
• Develop and deliver GMP, Data Integrity and inspection-readiness training to QC teams.
• Drive continuous improvement across laboratory systems, workflows, documentation and Quality culture.

• 15+ years of experience within GMP-regulated pharmaceutical or biopharmaceutical QC laboratory environments.
• Significant experience supporting or leading FDA Pre-Approval Inspection readiness programmes
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• Strong experience acting as an SME during FDA inspections, regulatory inspections or major client audits
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• Deep expertise in analytical method transfer and analytical method lifecycle management
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• Strong understanding of laboratory investigations, root cause analysis, CAPA and risk management.
• Good knowledge of FDA, cGMP, ICH, USP, EU GMP and global QC regulatory expectations
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• Strong understanding of Data Integrity and ALCOA+ principles
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• Demonstrated ability to resolve complex analytical, technical and compliance issues.
• Strong client-facing and stakeholder-management experience.
• Experience with laboratory start-up, expansion, technology transfer or major operational improvement programmes would be highly advantageous.