This fast growing, global company is looking to find a Quality Relationship Manager for in a prime pharmaceutical location! Their employees are dedicated to developing and manufacturing high quality medicines to patients all around the world!
- Report to the US Quality Director, while managing relations with external partners/CMOs.
- Supervise and guide Quality Operations.
- Review and approve SOPs, change controls, validation reports, investigations, and more as directed as well as approving these documents.
- Prepare for regulatory inspections at laboratories, CPO's, CMOs, and other vendors.
- Support all validation and technical transfers activities with external partners.
- Troubleshooting as needed.
- Manage Bulk Drug Product Release System.
- Work with CMOs on Quality Agreements and issues, as well as tracking on change controls, audits, rejections, etc.…
- Training and audits as needed.
- BS in Chemistry, Microbiology, Biology, or Pharmacy.
- 10+ years in Pharmaceutical Industry.
- GxP experience
- Knowledge of GxP Quality Systems, ICH guidance, FDA Regulation.
- Experience with sterile injectables and aseptic processing.
- Strong technical writing and computer skills.
- Able to travel to CMO and external sites (up to 20% travel).