Quality Systems & Compliance Leader — Onsite MN

Actalent; Minnesota; On-site; USD 85,000 - 120,000; Full time

Job summary

Actalent in Minneapolis, MN is seeking a Quality Systems and Compliance Manager to lead site quality activities, oversee audits (internal, customer, regulatory) and manage responses to findings to protect product quality and compliance.

Requirements include a Bachelor's degree in a relevant science or engineering discipline and at least 5 years in a cGMP manufacturing environment, with strong knowledge of FDA regulations and QMS.

Qualifications

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

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%).

Skills

Audit leadership

Root cause analysis

Quality investigations

Training & mentoring

Continuous Improvement

Performance management

HR partnership

Education

Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or related

Tools

QMS

Job description

Actalent in Minneapolis, MN is seeking a Quality Systems and Compliance Manager to lead site quality activities, oversee audits (internal, customer, regulatory) and manage responses to findings to protect product quality and compliance.

Requirements include a Bachelor's degree in a relevant science or engineering discipline and at least 5 years in a cGMP manufacturing environment, with strong knowledge of FDA regulations and QMS.