Senior Quality Control Lead

Fraser Dove International; Basel; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Fraser Dove International seeks a Quality Control professional to join its GMP-focused Basel operation. The role acts as a senior SME, leading FDA PAI readiness, regulatory inspections, and analytical method transfer across QC, QA, MSAT, Validation and Regulatory Affairs.

You will drive CAPA, data integrity, and lifecycle management to ensure compliant laboratory operations and successful client audits. Candidates should have 15+ years in GMP QC labs and strong leadership in inspection readiness

Qualifikationen

• 15+ years of experience within GMP-regulated pharmaceutical or biopharmaceutical QC laboratory environments.
• Significant experience supporting or leading FDA Pre-Approval Inspection readiness programmes.
• Strong experience acting as an SME during FDA inspections, regulatory inspections or major client audits.
• Deep expertise in analytical method transfer and analytical method lifecycle management.
• 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.
• Strong understanding of Data Integrity and ALCOA+ principles.
• Demonstrated ability to resolve complex analytical, technical and compliance issues.
• Strong client-facing and stakeholder-management experience.

Aufgaben

• 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.
• Provide technical leadership across analytical testing, including Drug Substance, In-Process Control and compendial testing.
• 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.

Kenntnisse

Quality Control

Subject Matter Expert

Regulatory inspections

CAPA

Data Integrity

Analytical testing

Method transfer

Root cause analysis

Risk management

Stakeholder management

GMP QC

Laboratory investigations

FDA inspections

Inspection readiness

Jobbeschreibung

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.

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.

Key responsibilities

• 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.
• Provide technical leadership across analytical testing, including Drug Substance, In-Process Control and compendial testing.
• 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.

We’re looking for someone with:

• 15+ years of experience within GMP-regulated pharmaceutical or biopharmaceutical QC laboratory environments.
• Significant experience supporting or leading FDA Pre-Approval Inspection readiness programmes.
• Strong experience acting as an SME during FDA inspections, regulatory inspections or major client audits.
• Deep expertise in analytical method transfer and analytical method lifecycle management.
• 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.
• Strong understanding of Data Integrity and ALCOA+ principles.
• 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.