Regulatory Compliance Manager

6 days ago


Vancouver, British Columbia, Canada Life Science Full time

**Job Summary**

We are seeking a highly experienced Quality Assurance Manager to join our Life Science company. The successful candidate will be responsible for ensuring the quality and compliance of our products and processes.

Key Responsibilities:

  • Develop and implement quality management systems to ensure compliance with regulatory requirements.
  • Conduct regular audits and inspections to identify and mitigate quality risks.
  • Collaborate with cross-functional teams to resolve quality-related issues and implement corrective actions.
  • Develop and maintain quality procedures, policies, and standards.
  • Review and approve quality-related documentation, including batch records and test reports.
  • Ensure compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) regulations.
  • Develop and implement training programs for quality-related topics.
  • Conduct internal and external audits to ensure compliance with regulatory requirements.
  • Develop and maintain quality agreements with suppliers and contract manufacturers.

Requirements:

  • Minimum BSc in Life Sciences or Pharmaceutical Sciences.
  • Minimum 8 years of experience in quality assurance in a pharmaceutical GMP environment.
  • Experience in conducting onsite and external audits to ensure compliance with GMPs.
  • Thorough understanding of Canadian GMP and ICH requirements for the manufacturing and release of drug products.


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