Supervisor, Quality Assurance Internal Operations
PCI Pharma Services2 days ago
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OnsiteFull-timeSenior
Summary
PCI Pharma Services is seeking a Supervisor, Quality Assurance Internal Operations to join their team in Madison, WI. The role involves leading QA Associates to ensure compliance with cGMP in the manufacturing of clinical and commercial drug products.
About the Role
As a Supervisor, Quality Assurance Internal Operations, you will be responsible for providing QA support for cGMP manufacturing operations, coordinating with cross-functional teams to improve procedures, overseeing Quality System Events, and leading QA oversight on the manufacturing floor. You will also supervise the Quality Assurance Department, ensure employee training, maintain quality metrics, and support external audits and regulatory inspections.
About You
Required:
- BS degree in a scientific discipline.
- Minimum 5+ years relevant GMP experience.
- Knowledge of FDA/ISO regulatory requirements and industry trends.
- Computer knowledge, including Microsoft Office and Windows.
- Excellent interpersonal skills with the ability to lead and make decisions.
- College Level Mathematical Skills.
Preferred:
- Experience supporting manufacturing and conducting training.
- Previous supervisory experience.
- Experience executing GMP quality systems in a pharmaceutical/biotech/medical device environment.
PCI Pharma Services
PCI is your world leading CDMO, providing integrated end-to-end drug development, manufacturing, and packaging solutions to increase product speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the delivery of CDMO services. With 30 sites across Australia, Canada, North America, the UK, and Europe and over 6000+ dedicated employees, together, delivering life changing therapies. Leading technology and continued investment enable us to deliver development to commercialization solutions throughout the product lifecycle, collaborating with our clients to improve the lives of patients globally.
Madison, WI