Senior Project Manager – GMP Remediation SME
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
s.
Not the right fit? Search for Project Manager jobs in Ottawa, Ontario, Canada
About Intellectt Inc
Welcome to Intellectt, where the convergence of emerging technologies, domain expertise and innovation drives excellence. Intellectt is a leading provider of Engineering, IT, and consulting services. Our dedication to customer success and our ability to scale on demand have propelled us to become one of the fastest-growing companies in the technology services segment in the US, over the last five years. Intellectt offers deep domain expertise in manufacturing, medical devices, healthcare, banking, financial services and other industries, alongside robust capabilities in emerging technologies like Artificial Intelligence (AI), NLP, Block Chain, Cloud and others. This unique combination enables our customers to navigate the complexities of today's technology and business landscape in order to achieve their goals.
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Senior Project Manager – GMP Remediation SME
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
s.
Not the right fit? Search for Project Manager jobs in Ottawa, Ontario, Canada
About Intellectt Inc
Welcome to Intellectt, where the convergence of emerging technologies, domain expertise and innovation drives excellence. Intellectt is a leading provider of Engineering, IT, and consulting services. Our dedication to customer success and our ability to scale on demand have propelled us to become one of the fastest-growing companies in the technology services segment in the US, over the last five years. Intellectt offers deep domain expertise in manufacturing, medical devices, healthcare, banking, financial services and other industries, alongside robust capabilities in emerging technologies like Artificial Intelligence (AI), NLP, Block Chain, Cloud and others. This unique combination enables our customers to navigate the complexities of today's technology and business landscape in order to achieve their goals.