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External 3rd Party Quality Manager

Date: Feb 23, 2021

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 Manager, External Quality is responsible for managing a portfolio of third party service providers and manufacturers of products supplying Apotex products for North Americas region.

The Manager is the primary point of contact on quality matters for the third party service providers and manufacturers under their responsibility, ensuring that products produced on behalf of Apotex are manufactured in accordance with cGMP, market regulatory requirements and meet our internal quality standards.

The Manager acts as a representative of Apotex interacting and negotiating with high-level management of third party entities. The role entails developing relationships, negotiating issues and communicating Apotex quality requirements with third party service providers and manufacturers.

 

 

Job Responsibilities

  • Liaises with internal quality functions on quality issues relating to third party manufacture. Acts as the primary point of contact with third party organizations on all quality related matters.
  • Participates in cross-functional new product introduction teams, ensuring quality and compliance are assured at launch and throughout commercialization. Acts as the point of contact for the transition from R&D Quality to Commercial Quality for co-development and in-licensed activities. 
  • Establishes a strong relationship with third party organizations.  Implements quality systems to monitor key quality metrics to enable evaluation of trends and continuous assessment of compliance risks.
  • Develops and negotiates quality agreements with third party organizations for new and existing third party operations involving Manufacturing/Packaging activities and all other activities, as required. Performs periodic reviews and ensures update of all current Quality Agreements.
  • Receives and reviews impact of significant deviations generated by third party manufacturers and concurs action steps, as required. Initiates and drives through to resolution the Apotex ‘Critical Incident Management’ process for notification of significant quality incidents associated with third party operations.
  • Reviews and approves third party manufacturer’s Stability, Process Validation and Analytical Validation protocols and Summary Reports, as required.
  • Reviews and approves third party manufacturer’s Change Controls, as required.
  • Provides oversight of third party manufacturer’s investigations into Customer Complaints, Quality Incidents and Deviations to ensure root causes are identified and effective CAPAs are developed and implemented.
  • Reviews Annual Product Reviews issued by third party manufacturers, along with Apotex sections of responsibility, and ensures recommendations are implemented in a timely manner.
  • Facilitates the Apotex External Audit process at key third party manufacturers. Defines appropriate action plans for improvement and periodically follows up and communicates action item closures.
  • Follows up with Third Party Organizations to obtain current GMP evidence to support Regulatory Compliance status.
  • Implements and applies a risk–based approach to third party manufacturing operations quality oversight and seeks efficiencies in operations without compromising product quality. Promotes continuous improvement activities.
  • Contributes to the development and improvement of External Quality Operations while working as a member of the EQ team to achieve all outcomes.
  • Performs all work in support of our Corporate Values.
  • Performs all work in accordance with all established regulatory and compliance and safety requirements.
  • Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities.
  • Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
  • Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
  • All other relevant duties as assigned

Job Requirements

  • Education
    • Minimum B.Sc. in Biology, Microbiology, Chemistry, Pharmacy or a related science
  • Knowledge, Skills and Abilities
    • Excellent understanding of Canadian and US Good Manufacturing Practices
    • Demonstrated, process-driven, analytical, and critical thinking
    • Ability to effectively manage multiple projects at the same time
    • Strong organizational, interpersonal and communication skills
    • Strong relationship management skills
  • Experience
    • Minimum 10 years experience in the pharmaceutical industry with relevant QA/QC/Mfg experience, preferably with multiple dosage forms.
    • Experience working in a sterile product manufacturing environment and/or with Biologics is preferred.

 

 

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.