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Team Lead, Global Investigations Program
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Team Lead, Global Investigations ProgramJoin to apply for the Team Lead, Global Investigations Program role at Apotex Inc.About Apotex Inc.Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. With nearly 6000 employees worldwide, Apotex operates in manufacturing, R&D, and commercial sectors. Our medicines are accessible in over 70 countries. We focus on developing and selling generic, biosimilar, and specialty products.Job SummaryThis permanent role involves overseeing the "Above Site review" and assessment of investigation reports in real-time to ensure compliant, sustainable, and consistent GMP investigations across the enterprise, meeting regulatory standards.The candidate will lead and manage the GIT team, enhancing oversight of investigations, CAPAs, and surveillance processes, applying scientific rigor, and ensuring effective CAPA implementation across all sites.Job ResponsibilitiesComplete real-time review and assessment of investigation reports, including Deviations, LIRs, Complaints, and CAPAs, using standard rubrics to ensure scientific rigor and proper root cause analysis.Ensure investigations identify true root causes, properly investigate human errors, and assess impact and risk, with appropriate corrective and preventive actions.Present site status reports to the GIT Steering Committee.Review investigation reports from sites as per requirements.Provide feedback and guidance to site investigators and senior leadership, facilitating meetings and reporting progress.Support training enhancements and serve as a resource for GIT, Specialists, QA Approvers, and Lead Investigators.Uphold company values and ensure compliance with ethical and regulatory standards.Job RequirementsBachelor’s or master’s degree in science or related field.Apotex Investigator Approver Certification Level 2: Investigation and CAPA Expert.Knowledge, Skills, and AbilitiesStrong knowledge of cGMPs/GMPs, scientific reasoning, and investigation processes.Ability to manage multiple priorities independently.Excellent communication, facilitation, and leadership skills.ExperienceAt least 10 years in regulatory compliance and quality in pharma or related industries.Minimum 5 years in investigations management.We are committed to an inclusive, accessible work environment. Accommodations are available upon request during the recruitment process.Additional DetailsSeniority level: Mid-Senior levelEmployment type: Full-timeJob function: Information TechnologyIndustry: Pharmaceutical Manufacturing #J-18808-Ljbffr
