Key Responsibilities: Conduct GMP compliance assessments of QC laboratory operations, processes, methods, and documentation. Perform gap assessments against Health Canada, FDA, ICH, and GMP requirements. Develop and implement remediation plans, CAPAs, and quality system improvements. Establish and document laboratory compliance surveillance processes. Support audit and inspection readiness activities. Collaborate with Quality, Regulatory, and Laboratory teams to ensure sustainable compliance. Required Qualifications: Bachelor's degree in Life Sciences, Chemistry, Microbiology, Pharmacy, or related field. 05+ years of GMP-regulated pharmaceutical, biotechnology, or medical device experience. Strong knowledge of GMP, GxP, Health Canada, FDA, ICH, CAPA, and Quality Systems. Proven experience with QC laboratory compliance, gap assessments, audits, and remediation projects. Excellent communication and stakeholder management skills. Preferred: Experience supporting regulatory inspections and GMP remediation initiatives. Consulting experience within pharmaceutical or life sciences environments.