Job Summary Seeking a Senior Regulatory / GMP SME with extensive experience in QC laboratory operations, GMP compliance, data integrity, regulatory inspections, and laboratory remediation programs within pharmaceutical or biotechnology environments.

Key Responsibilities Conduct GMP compliance and gap assessments of QC laboratory systems, processes, procedures, and documentation. Evaluate laboratory operations for compliance with GMP, Data Integrity, and regulatory requirements. Develop remediation strategies, corrective action plans, and risk-based compliance improvements. Review SOPs, CAPAs, deviations, investigations, OOS/OOT processes, and laboratory controls. Support regulatory inspections, audit readiness, and compliance monitoring activities. Verify implementation and effectiveness of corrective actions.

Required Qualifications 10+ years of GMP Quality or QC Laboratory experience. Strong expertise in GMP regulations, QC laboratory operations, Data Integrity, Quality Systems, and regulatory inspections. Proven experience conducting GMP gap assessments and remediation projects. Experience supporting FDA, Health Canada, and other regulatory agency inspections.