Quality Systems And Compliance Manager

We are seeking an experienced Quality Systems and Compliance Manager to lead a team of five Quality Assurance professionals and drive quality and compliance initiatives across the organization. This individual will maintain and enhance Quality Management System (QMS) processes, ensure regulatory compliance, support audit readiness, and foster a culture of continuous improvement.

Responsibilities

• Provide leadership, oversight, and support for site quality activities, including preparation for and management of internal, customer, and regulatory audits, as well as responses to audit findings (50%).
• Lead and support quality investigations, deviation management, root cause analysis, and timely closure of quality events while ensuring compliance with established procedures (20%).
• Train, mentor, and develop direct reports, ensuring team members maintain required competencies and compliance training requirements (10%).
• Drive Continuous Improvement initiatives to enhance product quality, operational efficiency, compliance performance, and quality system effectiveness (10%).
• Conduct performance management activities, including coaching, performance evaluations, goal setting, and employee development planning (5%).
• Partner with Human Resources on employee relations matters, staffing initiatives, and leadership development as needed (5%).

Requirements

• Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
• Minimum of 5 years of experience in a cGMP-regulated manufacturing environment.
• Demonstrated experience leading and supporting internal, customer, and regulatory audits, including FDA inspections.
• Strong knowledge of cGMP regulations, FDA requirements, and quality system standards applicable to regulated industries.
• Experience managing or supporting Quality Assurance and Quality Management Systems (QMS).

Pay

The pay range for this position is $85,000 - $120,000 per year.

Schedule

This is a permanent, fully onsite position based in Minneapolis, MN.