Quality Systems And Compliance Manager

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

Job Description

Quality Systems and Compliance Manager

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%).

Additional Skills & Qualifications

• 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).

Job Type & Location

This is a Permanent position based out of Minneapolis, MN.

Pay and Benefits

The pay range for this position is $85000.00 - $120000.00/yr.

Will provide full company benefits later in the interview process!

Workplace Type

This is a fully onsite position in Minneapolis,MN.

Application Deadline

This position is anticipated to close on Aug 24, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.