Coherus BioSciences
Senior Manager/Director Compliance
Redwood City, CA, United States · Director
Sponsorship not specifiedDetected 4313 days ago
GCPComplianceGMPLeadershipCommunicationCollaborationGxP
About the role
- Coherus Biosciences, Inc. is focused on delivering high quality biosimilar therapeutics that will expand the access of important medicines to patients worldwide.
- The Senior Manager/Director Compliance will be responsible for establishing and implementing global compliance systems for GMP/ GLP /GCP operations within the Coherus manufacturing and clinical operations network.
- Represent Quality and Compliance on internal project teams and externally to suppliers, CMO, CTL, or CRO's.
Responsibilities
- Develop metrics and reporting systems for risk identification and remediation of progress to plan.
- Develop and communicate corporate compliance policies and standards for GMP, GLP, and GCP operations.
- Develop risk-based recommendations for prioritization of risks and appropriate corrective/preventative actions.
Compensation
- Management of and oversight for outsourced GLP, GCP, and GMP audit professionals, including development of annual planning cycles and routine reporting of progress to plan.
Benefits
- Perform training and education internally in global compliance standards with particular emphasis on US, EU and Japan.
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