Compliance Program Manager

4 weeks ago


Whitby, Canada Thermo Fisher Scientific Inc. Full time
Job Description

As a key member of our team, you will be responsible for providing direction and management of the Compliance Program and associated activities. Your primary focus will be on ensuring that our facility meets current and anticipated regulatory requirements, including those of the FDA, HPFBI, EU, and ANVISA.

Key Responsibilities:
  • Direct teams responsible for reporting and site governance of Quality, Document Control, Training, Audits, Vendor Management, Regulatory & Licensing activities, Risk Management, Quality Management Review, and Quality Systems.
  • Ensure facility compliance systems are established and maintained as per regulatory requirements through internal audits, strategy meetings, compliance meetings, and other activities.
  • Oversee the management of Controlled Substances at the Patheon WRO site.
  • Develop and implement quality improvements to processes across PDS, Commercial, and Quality operations.
  • Direct the site Investigation team for resolution of all Deviations and OOS activities.
  • Provide timely responses to client regulatory requests.
  • Lead and mentor direct reports and site teams.
  • Manage departmental budget for proper staffing and expenses.
  • Maintain a Regulatory Watch for all recent GMP regulatory updates for the site and global.
  • Manage multiple small-medium projects and/or improvement initiatives.
Requirements:
  • Bachelor of Science (B.Sc.) in Chemistry, Pharmacy, or a science related to pharmaceutical analysis.
  • Minimum 15 years' experience in quality within the pharmaceutical industry.
  • Minimum 8 years previous supervisory and/or leadership experience.
  • Previous Project Management experience.
Knowledge, Skills, and Abilities:
  • Exceptional cGMP, GLP, and HPFBI/FDA compliance knowledge.
  • Proven leadership and problem-solving abilities.
  • Ability to prioritize multiple project deliverables.
  • Ability to motivate and influence.
  • Organized and detail-oriented.
  • Excellent written and verbal communication skills.
  • Knowledge of laboratory testing and equipment technologies an asset.


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