Quality Assurance Systems Manager Job at MBC Talent Connections, Albany, GA

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  • MBC Talent Connections
  • Albany, GA

Job Description

Job brief

We are looking for a Quality Assurance Systems Manager is responsible for overseeing quality systems with a focus on change control, document control, investigations, and CAPAs within a GMP-regulated environment. This role ensures compliance with internal policies, regulatory standards, and industry best practices, while supporting audit readiness and continuous improvement initiatives. The QA Systems Manager partners with cross-functional teams, provides oversight of quality records and metrics, and may supervise direct reports.

Responsibilities

  • Manage site quality systems, including change control, document control, and quality records management.
  • Review and approve investigations, CAPAs, and GMP documentation to ensure timely closure and regulatory compliance.
  • Prepare quality metrics, reports, and system performance updates for and leadership reviews.
  • Support internal and external audits, including responses and execution of corrective and preventive actions.
  • Collaborate with cross-functional teams to maintain a high level of audit readiness and promote continuous improvement.
  • Provide training and guidance on quality system requirements to site personnel.
  • Supervise and develop staff, ensuring effective resource management and knowledge transfer.

Requirements

  • Bachelors degree in a scientific, engineering, or related field preferred (equivalent experience considered).
  • 8+ years of quality experience in a regulated industry; medical device or pharmaceutical experience strongly preferred.
  • Proven experience with change control, document control, investigations, and CAPAs.
  • Familiarity with quality management systems (e.g., TrackWise, Documentum, SAP, or similar).
  • Knowledge of GMP, ISO, and EU regulatory requirements (MDR experience a plus).
  • Strong communication, organizational, and leadership skills.

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