Quality Manager

Position Overview: We are seeking a Quality Manager with approximately 5+ years of experience to support the client’s quality remediation efforts. The candidate will play a key role in addressing quality gaps, focusing on GMP, deviations, investigations, change controls, and data integrity. This role will support the urgent need to modernize the client’s quality systems, starting with sites in the northeast US.

Key Responsibilities:

Manage and execute quality processes, including deviations, investigations, change controls, and data integrity, ensuring compliance with GMP.
Support the establishment of modern quality fundamentals, assisting in the creation, review, and approval of master batch records and finished product releases.
Collaborate closely with the Senior Director and Change Management Director to implement quality improvements and address remediation actions.
Ensure data integrity across all quality systems, working closely with cross-functional teams to embed modern practices.
Assist in the execution of hundreds of remediation actions, ensuring adherence to deadlines and quality standards.

Qualifications:

5+ years of experience in a Quality role, ideally within 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 advantage.
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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