A Quality Manager is needed for a global healthcare leader that discovers, develops and distributes therapeutic solutions focused on patient's needs in the Swiftwater, PA area. This role will represent the site quality organization with expertise in Data Integrity. No per diem available.Responsibilities for the Quality Manager
Requirements for the Quality Manager
- Maintain currency with U.S. and European regulations related to Data Integrity.
- Perform Data Integrity risk assessment of manufacturing and laboratory systems.
- Evaluate proposed and existing manufacturing equipment, instrument systems and laboratory applications for Data Integrity gaps.
- Relevant quality assurance experience including expertise in GMP regulations gained from time served in a pharmaceutical, biotechnology and/or medical device industry required.
- 5+ years working in a GMP regulated environment required. 3+ years of experience in a computer systems validation required.
- Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on Data Integrity required.
<Benefits for the Quality Manager
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.