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Quality Compliance Manager
Actalent
Ensures site compliance with cGMP regulations and manages quality audits and corrective actions.
5d ago
$62 - $72
Intermediate (4-7 years), Expert & Leadership (13+ years), Experienced (8-12 years)
Contractor
St Louis, MO
Onsite
Company Size
5,000 Employees
Service Specialisms
Technical consultation
Performance analysis
Physical development
Injury prevention and recuperation
Sports psychology
360° Marketing
Consultancy with clubs and sporting entities
Legal services
Sector Specialisms
Utilities
Power
Automotive
Food and Beverage
Consumer Products
Industrial Goods
Manufacturing
Mechanical Engineering
Role
What you would be doing
edms management
cgmp support
inspection readiness
capa approval
regulatory compliance
internal audits
- Author, review, or approve documents within eDMS as needed.
- 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.
- Participate in inspection readiness program tasks and the execution of regulatory inspections.
- Lead or support client audits or inspections.
- Contribute to the oversight of Site Quality Records to ensure timely completion and adherence to requirements, including CAPA, Audit, and Change Control.
- Ensure the site’s compliance with FDA, EMA, and other cGMP regulations, including client requirements.
- Lead and participate in site internal audits, including execution, response approval, and supervising remediation activities.
- Approve corrective action plans and effectiveness checks for identified Quality System CAPAs.
What you bring
quality systems
gmp
fda/ema
pharma
science degree
audit experience
- Strong understanding of Quality Management Systems.
- 8-10 years of experience hosting audits and being front-facing in audits as well as inspection readiness.
- Experience in a GMP or regulated industry, preferably pharmaceuticals.
- Knowledge of pre-license/pre-approval inspection readiness and regulatory submissions is preferred.
- Internal and external audits, documentation, and risk management.
- Experience with regulatory inspections.
- Bachelor’s degree in a scientific field (Life Sciences, Biotechnology, or equivalent) is required.
- Regulatory compliance and auditing experience.
- In-depth knowledge of FDA/EMA regulatory requirements.
- 4-5 years of people management/leadership experience in Quality Assurance with a BS Degree in STEM.
- Experience with Quality Systems, including change control, root cause analysis, deviations, documentation management, and training systems.
- Time Off/Leave (PTO, Vacation or Sick Leave)
- Health Spending Account (HSA)
- Employee Assistance Program
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Transportation benefits
- Critical Illness, Accident, and Hospital
- Medical, dental & vision
- Short and long-term disability
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
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Interview process
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Visa SponsorshipInformation not given or found
Security clearanceInformation not given or found
Company
Overview
$1.3B Annual Revenue
Revenue Figure
Generated annually through a network of technical and consulting services.
27,500+ Consultants
Consultants Network
Comprises a global network of expert professionals across industries.
- Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner.
- Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services.
- Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects.
- Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems.
- Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.
- We empower people to realize their full potential by providing opportunities to grow and learn.
- We build lasting relationships based on trust, integrity, and respect.
- We champion innovation, continuously seeking creative solutions.
- We are committed to delivering exceptional results for our clients and employees.
- We foster a collaborative environment where team members contribute to collective success.
2050
Target Year
The company has set a goal to achieve net-zero emissions by the year 2050.
- focused on reducing its carbon footprint and enhancing environmental sustainability.
- committed to making energy-efficient investments and improving operational practices for sustainability.
- focuses on reducing waste and increasing recycling in its operations.
- This company prioritizes creating an inclusive workplace where diverse perspectives are valued.
- The organization strives to increase gender diversity and empower women at all levels.
- The company regularly monitors and tracks progress on gender-related diversity goals.
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