Director, Clinical Quality Assurance (CQA)

Title: Director, Clinical Quality Assurance (CQA) Reports to: Chief Medical Officer Location: Redwood City, CA Classification: Exempt Overview: The Director, Clinical Quality Assurance (CQA) will be accountable for Clinical Quality Assurance Systems for Coherus clinical programs and global drug safety and pharmacovigilance activities. This role is responsible for ensuring that Coherus plans and systems that govern clinical studies are in compliance with regulatory requirements, industry best practices (ie GCP, GLP, GVP) and company SOPs by working with Quality management, external auditors, and other internal Clinical functions.The position will also be responsible for supporting and hosting regulatory inspections and defining and implementing clinical compliance plans to include GCP/GCLP/GVP audits of service providers, CROs, investigator sites, bioanalytical laboratories, and Drug Safety and Pharmacovigilance systems and processes. A key responsibility of this position will be to provide proactive strategic guidance to improve and continue to evolve quality processes and mitigate risks throughout the clinical development lifecycle. Responsibilities : Assure that Coherus GCP, GCLP, and GVP systems and records are compliant with global regulatory requirements. Partner at a senior level with Head of Quality to ensure globally aligned, timely, and regulatory‑compliant audit and inspection responses, while driving clear accountability and ownership among fuctional Heads of departments (Clin Ops and PV). Must work hands on within the Coherus Quality Management System infrastructure and systems and adapt and be responsible for developing processes and producre under the Coherus Quality Manual. Quality oversight for the development, closure, review, approval and management of PV-related CAPAs and audit findings—internal and external—ensuring strategic remediation, risk mitigation, and sustainable quality improvements across the PV system. Represent Clinical Quality on int