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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 strong decision-making recommendations, advice and action plans for investigations, gap analyses and risk assessments.
Works closely with clients to resolve investigations.
Manages, develops and prioritizes support for client and regulatory compliance audits.
Manages creating and tracking of project timelines, tasks, responsibilities and activities to meet client and internal expectations.
Manages the performance of the QMS Investigations group and ensures close out of investigations to enable product release in a timely manner.
Builds effective partnerships with department leadership to help drive the business toward achieving company objectives.
Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication.
Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.
Foster a safe and environmentally sustainable workplace by ensuring compliance with all PCI EHS policies and procedures.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position.…