Project Leader - Corporate Quality and Compliance

Date: Jun 18, 2022

Location: North York, ON, CA, M9L 1T9

Company: Apotex

 

About Apotex Inc.

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations.  Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.

Job Summary

 

The Project Leader, Global Field & Market Response is responsible for facilitating functions related to Critical Event Management/Escalation, Regulatory Notification and Product Recall. This also includes liaising with local and international regulatory agencies, customers, vendors and affiliates.

Job Responsibilities

 

  • Responsible for ensuring Escalations, Field Actions and Regulatory Communications are managed and completed in a timely manner as per applicable regulatory requirements and Apotex’s approved procedures.
  • Liaises with Apotex Affiliates to provide appropriate notification of critical events and coordinate investigations, recall activities and procedures.
  • Assist the Manager, Global Field & Market Response in meeting departmental goals and objectives.
  • Completes Recall Submissions and Recall Status Reports.
  • Ensures Recall and Escalation related documentation are issued; reports and files are completed and follow-up is conducted for corrective and preventive actions related to Recalls, Regulatory Notifications including Field Alert Reports.
  • Participates in the preparation of Apotex Escalation Committee Meeting materials.
  • Creates and drives to completion change controls as well as manages the review and approval process for centralized SOPs originated from Global Field & Market response department.
  • Ensure that all centralized function SOPs (applicable to the Global Field & Market Response Department) are issued as per the required standards and are revised within the required timelines.
  • Provides support during revision of Global Policy and Global Standard Operating Procedures applicable to the Global Field and Market Response team (as needed).
  • Recommends and participates in the implementation of process improvement initiatives.
  • Ensures that all work is performed in full compliance with Good Manufacturing Practices, Standard Operating Procedures, established safety standards, and regulatory requirements. Responsible and accountable for following and implementing safety regulations in accordance with the Occupational Health and Safety Act, Apotex’s Health and Safety Policies and Safe Work Procedures (SWPs).
  • Compiles/summarizes monthly and quarterly trend reports as required. Creates monthly metrics for departmental work as related to Escalation, Recalls and Regulatory Notifications.
  • Works in a safe manner collaborating as a team member to achieve all outcomes.
  • Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
  • Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
  • All other relevant duties as assigned.

Job Requirements

 

  • Education
    • Sc. in Chemistry, Biochemistry or a related science (or an equivalent combination of post-secondary education and related work experience).
  • Knowledge, Skills and Abilities
    • Knowledgeable regarding GMP requirements for drug products.
    • Strong interpersonal, communication and facilitation skills.
    • Excellent oral and written English communication skills.
    • Ability to work independently with minimal supervision.
    • Strong organizational and time management skills.
    • Proficiency commensurate with job requirements in SAP, Word, Excel, Access and other Windows software packages.
  • Experience
    • Minimum five years of experience in a quality assurance or quality control role in the pharmaceutical industry.

COVID-19 VACCINATION POLICY: In accordance with Apotex Inc. (“Apotex”) policy, as of November 15, 2021, all individuals entering a Canadian site (including but not limited to employees, visitors, contractors and agency workers) must be fully vaccinated against COVID-19 in accordance with the current government requirements.  Further, all employees must maintain all future booster vaccines as approved and recommended by Health Canada.  Accommodation from these requirements for reasons pursuant to the Ontario Human Rights Code, or any other applicable law (most commonly for medical and/or religious reasons) will be reviewed and considered by Apotex.

 

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.