Job Summary
A global biopharmaceutical company has an open position for a Remote Biologic Product Quality Manager.
Candidates will be responsible for the following:
- Ensures that all biologic products manufactured at external partners and alliances meet applicable regulatory requirements
- Support review of regulatory filings, requests for information and subsequent supplemental packages as required
- Advise support groups on aspects of GMP compliance
Must meet the following requirements for consideration:
- Travel Requirements: 25%
- Bachelor’s Degree or higher in a Scientific or Technical Discipline
- Minimum of 5 years experience in the pharmaceutical industry
- Hands on experience with change control processes in GCM Trackwise