Operations Manager, Global External Operations
On-siteSan Rafael, California, United States
Job Summary
Execute production plans at Contract Manufacturing Organizations to deliver uninterrupted clinical and commercial supply. Manage CMO meeting schedules, resolve supply constraints, and oversee escalations within the process and GEO teams. Conduct root cause analysis, lead technology transfers, and monitor production campaigns to ensure cGMP compliance. Coordinate material movement, evaluate process changes, and maintain visual dashboards for business oversight. Partner with SMEs to support operational readiness for new CMOs and new processing steps. Represent the GEO team at VPT and VST meetings while driving cost reduction initiatives.
Required Qualifications
- Minimum requirement of 5 years leadership experience in Operations, Supply Chain or Quality
- BS/BA degree; life sciences, business, or supply chain management
- Will have an excellent understanding of the processes/unit operations
- Demonstrated ability in leading/managing cross functional, multi-disciplinary teams
- Ability to guide and support cross functional teams in the resolution of short-term issues and sustained performance for long-term goals
- Proven track records in effective decision making
- A high level of initiative, influencing, coaching as well as excellent organizational skills
- Experienced in working and managing in a regulated GXP environment
- Strong stakeholder and relationship management experience
- Experience in supply planning or inventory management
Desired Qualifications
- Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is desired
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