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Patheon
Manager, Quality Systems
Toronto - Canada
Posted March 09, 2017

Join us as We Transform How Pharmaceuticals are Made.

Patheon is looking for people who are passionate about making a difference in people’s lives. Patheon is in need of proven leaders to nurture talent, build effective teams and drive engagement in an environment where people are motivated to do their best for the company, its clients and their patients. To inspire collaboration and innovation.
Summary

In this role, you would be responsible for successfully managing the activities of the Quality Assurance (QA) Department relating to quality review and on time dispositions for the site, including the evaluation documents for quality processes related to Pharmaceutical Development Services (PDS) and Commercial Operations. 

 

Key Requirements
  • Reviews, approves, and coordinates follow-up actions of Quality Incident Reports/Quality Deviation Reports (QIR/QDR)
  • Manages QA administration and systems within the QA department
  • Reviews and approves Validation protocols and report approvals
  • Develops internal QA and site systems, such as quality on the floor, corporate metrics, and ensuring proper scheduling for product dispositions to meet site needs, whilst ensuring adherence to Good Manufacturing Practices & other regulatory requirements
  • Oversees training of QA systems staff
  • Prepares monthly reports for Director of Quality Operations or as requested
  • Selects, develops and evaluates staff to ensure the efficient operation of the function and works with and advises staff on administrative policies and procedures
  • Other duties as required.
Qualifications
  • Bachelor of Science (B.Sc.) in Chemistry, Pharmacy, Microbiology, or Biology.
  • Minimum 7 years of Quality Assurance experience within the pharmaceutical industry.
  • Minimum 3 years previous supervisory experience (with production experience considered an asset, and equivalent combinations of education, training, and relevant work experience may also be considered).
  • Good Manufacturing Practices and United States Food & Drug Administration (FDA) compliance knowledge.
  • Interpersonal and communication skills (both oral and written), leadership ability, and organizational skills.
  • Possesses highly developed quality, regulatory and production mindset including an appreciation for client service and contract manufacturing.
  • Proficiency with the English language.
  • Demonstrated commitment to our fundamental values of Integrity, Respect & Excellence.

Help Us Make a Healthier World.

Patheon provides development and manufacturing services for more than 800 pharmaceuticals, including nearly a fifth of the world’s top selling drugs. We’ve helped our clients earn more than twice as many U.S. FDA approvals than any other CDMO. Are you as committed as we are to exceeding expectations with high-quality solutions to complex problems? If so, we want to talk to you about making a healthier world... together. Join us at patheon.com
Disclaimer

Patheon Inc. is an equal opportunity employer and is committed to the principle of diversity and is particularly interested in receiving applications from a broad spectrum of people. Accommodations for job applicants with disabilities are available upon request.

 

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