Change Control Owner
Dawar Consulting•Santa Monica, CA
•Hybrid
About The Position
The Senior Specialist will work closely with the GSC organization to own and manage Supply Chain initiated change controls by our Global and Regional Supply Chain teams as well partner with other Technical Operations functions: Quality, Process Development, and Manufacturing. These partnerships ensure that GSC owned change controls meet and/or exceed Quality Management System requirements, meet compliance requirements, and are implemented flawlessly per established timelines.
Requirements
- 5+ years of Change Control experience, preferably in a GMP/GxP environment.
- Biotech/pharma experience required.
- Hands-on experience with QMS/eQMS systems such as Veeva QMS, TrackWise, MasterControl or Oracle Agile preferred.
Responsibilities
- Own and manage GMP/GxP Change Control records from initiation through closure.
- Track approvals, implementation activities, milestones, risks, dependencies and deadlines.
- Coordinate cross-functional meetings and stakeholder communications.
- Ensure change controls meet QMS, compliance and quality requirements.
- Maintain change-control trackers and provide status reporting.
- Identify delays/risks and drive timely escalation and resolution.
- Support continuous improvement of Change Control processes.
Benefits
- Medical
- Paid Sick Leave
- 401 (k)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
