Manage GMP/GxP change control records from initiation through closure for Global Supply Chain. Track approvals, milestones, risks, and dependencies; coordinate cross-functional stakeholders, maintain trackers, report status, escalate delays, and drive continuous improvement of change control processes to meet QMS and compliance requirements.
Our client, a world leader in biotechnology and life sciences, is looking for a “Change Control Owner”.
Location: Hybrid in Santa Monica; will transition to El Segundo in 2027
Job Duration: Long-Term Contract (Possibility Of Extension)
Rate: $70-$78/hr on W2
Company Benefits: Medical, Paid Sick Leave, 401 (k)
About the Role
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.
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.
Qualifications
- 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.
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