Quality Assurance Director

1 week ago


Michigan, United States G&L Healthcare Advisors Full time
Quality Assurance Manager

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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