QE III/Regulatory Compliance Specialist

Quality Engineer III/Regulatory Compliance Specialist

The Regulatory Compliance Specialist plays a crucial role in ensuring the organization's adherence to regulatory standards and internal policies. This position involves leading complex audit preparations, regulatory inspections, and developing strategic compliance initiatives. Additionally, the Specialist mentors junior team members and acts as a key point of contact for compliance-related matters.

Responsibilities

• Lead preparations for internal and client audits and regulatory inspections.
• Conduct comprehensive internal audits to assess compliance with organizational and regulatory standards.
• Provide expert guidance and support during external audits and inspections.
• Develop and implement inspection readiness programs.
• Conduct periodic compliance assessments to ensure continuous inspection readiness.
• Assist in maintaining site and program readiness documentation.
• Collaborate with the Regulatory Compliance Manager to develop and implement compliance strategies.
• Analyze audit findings and regulatory changes to recommend strategic compliance initiatives.
• Draft and update compliance policies and procedures.
• Develop detailed responses to audit and inspection findings.
• Oversee the implementation of corrective and preventive actions (CAPAs).
• Track and report on CAPA status and effectiveness.
• Mentor and provide guidance to junior compliance team members.
• Assist in developing and delivering compliance training programs.
• Promote a culture of compliance within the organization.
• Maintain accurate records of audits, inspections, and compliance activities.
• Prepare compliance reports and presentations for senior management.

Essential Skills

• Minimum of 7 years of experience in a Quality Assurance role.
• BS Degree in STEM.
• Experience in pharmaceutical or medical device industry, with preference for pharmaceuticals.
• Experience in a GMP or regulated industry.
• 5+ years experience hosting audits and being front-facing in audits and inspection readiness.
• Experience with Quality Systems, including change control, root cause analysis, deviations, documentation management, and training system.
• In-depth knowledge of regulatory requirements and standards.
• Strong analytical and problem-solving abilities.
• Excellent communication and interpersonal skills.

Additional Skills & Qualifications

• Professional certification in compliance or risk management preferred.
• Experience in developing and implementing compliance programs.
• Proficient in compliance management software and tools.
• Leadership and mentoring capabilities.
• Strategic thinking.
• Attention to detail.
• Integrity and ethical behavior.
• Adaptability and flexibility.

Work Environment

The work environment involves office or desk work, typically Monday to Friday with normal day hours, but flexibility is required to accommodate audit schedules. This position requires presence during core hours, and the individual may need to arrive early or stay late depending on audit requirements. The role offers a great opportunity to work with large-scale biological and chemistry pharma operations, contributing to meaningful work like developing pharmaceuticals used for autoimmune diseases. The organization values innovative thinking and a culture dedicated to customer-centric approaches.

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 $43.00 - $55.29/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 16, 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.