*Qualifications Graduate or professional degree in a scientific or health administration discipline, or an equivalent combination of education and experience. Minimum of five (5) years of relevant experience, including at least three (3) years in a leadership role directly supporting GMP and GVP audits. ASQ Certified Quality Auditor (CQA) and/or ISO Quality Auditor certification (or other relevant quality certification) is required. Lean Six Sigma Certification is a plus. Pharmacovigilance Certification is a plus. Experience in a healthcare environment is a plus. Bilingual (French/English) is a plus. In-depth understanding of GxP regulations, including\: Good Manufacturing Practices (GMP) Good Clinical Practices (GCP) Good Pharmacovigilance Practices (GVP) Good Documentation Practices (GDP) ASQ Quality guidelines ISO 9001 requirements and standards Additional Skills Experience working in a Pharmaceutical GMP environment is desired. Experience auditing third-party vendors, including 3PL (third-party logistics) activities. Strong business writing skills. Experience in incident management and investigations. Proficient in technical writing, including policies, SOPs, work instructions, and CAPA documentation. Experienced in internal and external Pharma audits, Health Canada inspections, and ISO audits. Familiarity with Quality Systems, including but not limited to\: Document Management Systems (DMS) Change Control Quality Management Systems (QMS) Learning Management Systems (LMS)