Quality Assurance Director
1 week ago
At G&L Healthcare Advisors, we are seeking a seasoned Quality Assurance Manager to support our client's quality remediation efforts. This role will play a critical part in addressing quality gaps, focusing on GMP, deviations, investigations, change controls, and data integrity.
Key Responsibilities:
- Develop and execute quality processes, ensuring compliance with GMP regulations.
- Collaborate with cross-functional teams to establish modern quality fundamentals, including master batch record review and finished product release.
- Work closely with the Senior Director and Change Management Director to implement quality improvements and address remediation actions.
- Ensure data integrity across all quality systems, embedding modern practices throughout the organization.
- Support the execution of remediation actions, ensuring adherence to deadlines and quality standards.
Qualifications:
- 5+ years of experience in a Quality role, preferably in a pharmaceutical or CMO environment.
- Strong knowledge of GMP, deviations, investigations, change controls, and data integrity.
- Experience with master batch record review and finished product release is an asset.
- Ability to support significant quality transformations in a fast-paced environment.
- Strong problem-solving skills, with an adaptable mindset to manage changes in an evolving environment.
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