Job Description We are seeking a Senior Regulatory & GMP Subject Matter Expert with extensive experience in Quality Control laboratories, GMP compliance, regulatory expectations, and laboratory remediation initiatives. The ideal candidate will lead compliance assessments, identify GMP gaps, develop remediation strategies, strengthen quality systems, and support inspection readiness while ensuring alignment with global regulatory requirements. Key Skills Develop and implement documented surveillance and compliance monitoring processes. Conduct GMP gap assessments of QC laboratory systems, procedures, processes, documentation, and practices. Evaluate laboratory operations for compliance with GMP regulations, Data Integrity requirements, laboratory best practices, and Health Canada, FDA, and international regulatory standards. Develop phased corrective action and remediation plans. Prioritize compliance risks and remediation activities. Support implementation and effectiveness verification of corrective actions. Review SOPs, investigations, CAPAs, deviations, OOS/OOT processes, and laboratory controls. Support inspection readiness and audit preparation activities. Required Qualifications 10+ years of GMP Quality or QC Laboratory experience. Strong knowledge of GMP regulations. Strong understanding of QC laboratory operations. Expertise in Data Integrity. Experience with regulatory inspections. Strong knowledge of Quality Systems. Demonstrated experience performing GMP gap assessments and remediation activities. Experience supporting regulatory agency inspections. Additional Skills Compliance assessment expertise. Laboratory remediation planning. Compliance risk prioritization. Corrective action implementation and effectiveness verification. Inspection readiness and audit support.