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Senior Project Manager – GMP Remediation SME

Ottawa, Ontario, Canada
Senior Level
CONTRACTOR

About the role

Job Summary: Seeking an experienced Senior Project Manager to lead GMP remediation, quality transformation, compliance improvement, and inspection readiness initiatives within pharmaceutical, biotechnology, or other GMP-regulated environments.

Key Responsibilities :Lead planning and execution of GMP remediation programs .Coordinate cross-functional teams across Quality, Regulatory, Manufacturing, QC, Validation, and Operations .Develop project plans, timelines, milestones, and risk mitigation strategies .Drive CAPA implementation and track remediation activities to closure .Provide executive-level project updates and stakeholder communications .Support regulatory inspection readiness and compliance initiatives

. Required Qualification s:10+ years of experience in pharmaceutical, biotech, or GMP-regulated industrie s.Proven experience leading GMP remediation, compliance, or quality transformation program s.Strong knowledge of FDA, Health Canada, EU GMP, and ICH regulation s.Demonstrated success managing complex cross-functional project s.Excellent communication, leadership, and stakeholder management skill

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About Intellectt Inc

Engineering Services