Quality Compliance Manager 62-72/HR

Actalent • Saint Louis, MO • 2h ago

Quality Compliance Manager

Job Description

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

Quality assurance and quality management systems.

4-5 years of people management/leadership experience in Quality Assurance with a BS Degree in STEM.

Experience in a GMP or regulated industry, preferably pharmaceuticals.

8-10 years of experience hosting audits and being front-facing in audits as well as inspection readiness.

Experience with Quality Systems, including change control, root cause analysis, deviations, documentation management, and training systems.

Regulatory compliance and auditing experience.

Internal and external audits, documentation, and risk management.

Additional Skills & Qualifications

Bachelor's degree in a scientific field (Life Sciences, Biotechnology, or equivalent) is required.

In-depth knowledge of FDA/EMA regulatory requirements.

Strong understanding of Quality Management Systems.

Knowledge of pre-license/pre-approval inspection readiness and regulatory submissions is preferred.

Experience with regulatory inspections.

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 Oct 2, 2025.

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