Quality Compliance Manager

Quality Compliance Manager

The Quality Compliance Manager plays a crucial role in maintaining site compliance by ensuring quality records meet required standards. This role involves participating in site inspection readiness activities, conducting internal audits of quality systems and GMP functions, supporting client audits, and managing corrective actions. The individual will ensure compliance with FDA, EMA, and other cGMP regulations.

Responsibilities

• Ensure the site's compliance with FDA, EMA, and other cGMP regulations, including client requirements.
• Contribute to the oversight of Site Quality Records to ensure timely completion and adherence to requirements, including CAPA, Audit, and Change Control.
• Lead and participate in site internal audits, including execution, response approval, and supervising remediation activities.
• Lead or support client audits or inspections.
• Approve corrective action plans and effectiveness checks for identified Quality System CAPAs.
• Author, review, or approve documents within eDMS as needed.
• Participate in inspection readiness program tasks and the execution of regulatory inspections.
• Provide knowledge of current cGMP requirements and trends to ensure appropriate technical support on all quality / compliance-related matters is provided to the site.
• Train and mentor junior staff members.

Essential Skills

Additional Skills & Qualifications

Work Environment

This is an office / desk work role, Monday to Friday, with normal day hours. Flexibility is required as you may need to be available early or late depending on the audit schedule. The work environment is innovative and impactful, with a focus on customer satisfaction and making a difference in the world. You will be part of a fast-growing, global organization that values passion and unique contributions.

Job Type & Location

This is a Contract to Hire position based out of Saint Louis, Missouri.

Pay and Benefits

The pay range for this position is $62.00 - $72.00 / hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following :

Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off / Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Saint Louis, MO.

Application Deadline

This position is anticipated to close on Sep 30, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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.