Compliance Program Manager

2 weeks ago


Whitby, Canada Thermo Fisher Scientific Full time
Job Title: Compliance Program ManagerAbout the Role:

As a Compliance Program Manager at Thermo Fisher Scientific, you will be responsible for directing and managing the Compliance Program and associated activities. This includes ensuring Compliance/Quality Systems are in place and periodically audited to meet current and anticipated regulatory requirements.

Key Responsibilities:
  • Ensure facility compliance systems are established as per FDA, HPFBI, and other Regulatory Agency requirements.
  • Ensure the facility is always in pre-approval Inspection (PAI) readiness mode.
  • Develop and implement Good Manufacturing Practices training programs for all functional areas.
  • Review metrics for Standard Operating Procedure (SOP) documentation control and allocate resources to prevent backlogs.
  • Assist with the vendor management program to meet compliance expectations for Canadian Operations.
  • Oversee coordination and performance of Quality Systems linked to Investigative, Change Control, and Corrective and Preventative Actions (CAPA) initiatives.
  • Provide quarterly Investigation and CAPA evaluation within the Compliance department.
  • Evaluate, challenge, and implement quality improvements to processes across PDS, Commercial, and Quality operations.
Requirements:
  • Bachelor of Science (B.Sc.) in Chemistry, Pharmacy, or a science-related field.
  • Minimum 15 years' experience in quality within the pharmaceutical industry.
  • Minimum 8 years previous supervisory and/or leadership experience.
  • Previous Project Management experience.


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