Sr Manager – Quality DPCS
| Company | Simtra BioPharma Solutions |
|---|---|
| Location | Bloomington, IN, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s Degree in scientific or related discipline required
- Minimum 7 years of experience in a pharmaceutical or biotech industry required
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
Responsibilities
- Build a phase-based approach to adapt Simtra quality systems to DP clinical manufacturing through life cycle of a biological product or API
- Integrate FDA CFR and ICH guidelines at a minimum
- Accountable for integration of quality by Design approach to process development and process controls
- Adapt qualification and validation studies to pre-commercial phases requirements
- Develop a data management strategy adapted to development and pre-commercial services
- Ensure high level of data integrity and traceability
- Accountable to establish adequate risks management levels from pre-clinical to late clinical phase manufacturing
- Ensure good practices in the process and analytical development laboratories
- Represents point of contact between DPCS and QC for prioritization, risk management and escalation as needed
- Ensure quality oversight of pre-commercial manufacturing on the shop floor
- Responsible for the quality oversight of all GMP documentation & training for DPCS
- Develop strong partnership with the Head of Development & Pre-commercial Services on site
- Support customer’s visits and meetings as appropriate
Preferred Qualifications
-
No preferred qualifications provided.