Manager, QMS Investigations
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Summary:
The Manager, QMS Investigations position provides expert-level technical and people leadership for the Investigations team, overseeing the investigation, documentation, and resolution of deviations, change controls, out-of-specification reports, corrective and preventive actions, and other CGMP quality system records. This role is responsible for directing daily operations, ensuring timely and compliant execution of investigations, and leading team performance to support business objectives and product release timelines.
The Manager oversees departmental metrics, gap assessments, and risk management initiatives while fostering collaboration across Quality, Manufacturing, Microbiology, Facilities, and other functional areas. As an established people leader within the department, this position is accountable for employee development, performance management, engagement, and building a high-performing team culture while ensuring compliance with regulatory, client, and company requirements. Additionally, the Manager supports the development of new or emerging department leaders by providing mentorship, guidance, and opportunities for leading projects and people.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The
essential duties and responsibilities include the following, but other duties may be assigned.
- Investigates, identifies problems and proposes solutions while managing diligent execution of day-to-day operations.
- Manages, develops and prioritizes investigations and resolution of complex issues and potential problems related to manufacturing.
- Authors and revises complex documents including compliance, change controls and other technical documentation.
- Manages supporting interdisciplinary working teams with ...
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