Regulatory Compliance Manager
6 days ago
**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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