Senior QC SME - FDA PAI Readiness & Method Transfer Lead

Fraser Dove International; Basel; On-site; CHF 180,000 - 240,000; Full time

Job summary

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

Qualifications

• 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.

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.

Skills

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

Job description

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