Global Investigations Program Team Lead

About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

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Job Summary
This is a permanent role, responsible for the "Above Site review" and assessment of investigation reports on a real time basis to ensure, compliant, sustainable and consistent quality of GMP investigations across the Enterprise as per regulatory requirements and expectations.

This role will be responsible for leading, managing and overseeing GIT team of Specialists contributing to strengthening the above-site review/oversight to the site's execution of Investigations, CAPA, and surveillance process to ensure application of scientific rigor for investigations and effective CAPAs are implemented across all sites.

Job Responsibilities

Above Site Review as part of GIT

• Completes Above Site real time review, assessment and scoring of all aspects of Investigations including Deviations, LIRs, Complaints, CAPAs submitted by respective Site Investigation Team (SIT), using preapproved standard rubrics to ensure scientific rigor and discipline is applied to identify root cause for Investigations, including proposal of effective CAPAs, prior to investigation closure. Implement/reinforce Investigator and Approver Certification (IAC) rubrics / evaluation based education and coaching for site Quality decisions on investigations and CAPA, drive continuous improvement and standardization across the organization.
• Ensures that investigations identify the true root cause based on Scientific rigor, Human Error causes are properly investigated, Impact and Risk level are appropriately assessed, and the corrective and preventative actions are commensurate.
• Presents site status reports on the review completion and findings to the GIT Steering Committee leadership.
• Ensures that review of assigned number of investigation reports for each site is completed as per required

• In collaboration with Global Investigation Team (GIT) and Global Quality & Compliance:

• Provides feedback on the investigation review findings and guidance on improvements to SIT to be addressed before investigation closure.

• Facilitates and leads meetings, as required with Global / Site investigators and Senior Leadership.
• Processes data, compiles reports and communicates progress related to investigations / CAPAs for Enterprise
• Identifies and makes proposals for strengthening training with enhancements to training materials or
• Acts as resource providing support and guidance to GIT, Specialists, QA Approvers and Lead Investigators at the site
• Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, and Passion; Demonstrate strong and visible support of our values.
• Performs all work in compliance with our Code of Conduct and Business Ethics, related policies and with the legal and regulatory requirements that apply to our job activities.

Job Requirements

• Education

• Bachelor's or master's degree in science or a related

• Apotex Investigator Approver Certification Level 2: Investigation and CAPA Expert

• Knowledge, Skills and Abilities

• Strong knowledge and application of cGMPs/GMPs in a pharmaceutical manufacturing and in QA/QC environment and critical thinking skills

• Deep understanding of Investigation process and CAPA management
• Demonstrated ability to work independently and effectively manage multiple priorities in a fast paced and changing environment.
• Excellent interpersonal, communication, presentation, and facilitation
• Critical thinking and application of scientific reasoning

• Demonstrated ability to work in partnership with and build strong links to all areas of the business. Ability to provide effective feedback and coaching to others.

• Experience

• Minimum of 10 years of regulatory compliance and quality experience in the pharmaceutical or related industry with experience in quality, production or laboratory systems

• Minimum of 5 years of practical experience in Investigations management.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.