quality assurance

Key Responsibilities

The 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.

Key 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 site 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.

Qualifications

• Bachelor’s 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.