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Director, Compliance
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$200
Full-time
- GxP Compliance is accountable for establishing procedures and processes for inspection readiness and the surveillance of GxP compliance at Coherus, supporting awareness of compliance requirements through surveillance of industry requirements, and to support due diligence activities.
- Develop and communicate corporate compliance policies and standards for GMP operations and partner with peers in clinical operations to support the development and maintenance of similar documents for GVP, GLP, and GCP operations
- Experience in authorship or review of CMC and/or clinical regulatory submissions.
- Experience in Phase III drug development GxP environment and commercial operations.
- Excellent communication skills, and comfortable assuming leadership within teams and with external CMO's, CTL's, and CRO's.
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