About this role
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. Develop metrics and systems for annual audit schedules, risk identification and reporting. Ensure that systems and records are compliant with global regulatory requirements.
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.
Development of a global compliance program for GMP, GLP and GCP operations of Coherus Biosciences.
Develop metrics and reporting systems for risk identification and remediation of progress to plan.
Conduct GMP audits of contract manufacturing sites, labs, suppliers and internal operations.
Oversee conduct of GCP and GLP audits.
Perform training and education internally in global compliance standards with particular emphasis on US, EU and Japan.
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.
Bachelors’ degree in Chemical or Life Sciences. Advanced degree preferred
15 years or greater experience in Biotechnology quality and compliance roles.
Strong knowledge of global GXP expectations and ICH requirements
Experience in authorship or review of CMC regulatory submissions.
Experience in Phase III drug development GMP environment and commercial operations.
Excellent collaboration skills.
Work independently
Comfortable working in a fast paced and highly expert environment.
Excellent communication skills, and comfortable assuming leadership within teams and with external CMO’s, CTL’s, and CRO’s.
Our Company offers excellent benefits including medical, dental, vision, life, short and long term disability plans, 401k, FSA, vacations, paid holidays and health club reimbursement.