Director, Clinical Quality Assurance

About the role

This position directs clinical quality assurance for Coherus Oncology programs, overseeing activities from first patient dosing through global safety reporting. The role ensures studies remain compliant and inspection-ready across internal teams and external partners. You will translate complex regulatory requirements into clear, actionable standards for clinical operations and pharmacovigilance.

Location: USA

Engagement: Full-time, exempt

Compensation: $140,000.00 base; $20,000.00 target bonus; equity

What you will do

You will set clinical quality strategy for early-phase through late-phase studies conducted across international and domestic sites. You will champion adherence to GCP, GCLP, and GVP requirements while coordinating audit and inspection responses with senior leadership. You will design, maintain, and evolve Coherus processes documented within the Coherus Quality Manual to support clinical operations globally. You will manage the full lifecycle of CAPA and audit findings to drive risk mitigation and sustained quality improvements within pharmacovigilance systems. You will partner with the Head of Quality to align audit strategies and ensure timely, transparent, and regulatory-compliant responses. You will provide guidance to external CROs, bioanalytical laboratories, and vendors regarding compliance standards and quality expectations for clinical studies. You will assess GCP, GCLP, and GVP risk areas and create or update clinical risk management procedures in collaboration with affected teams. You will plan, execute, and close GCP, GCLP, and GVP audits for both domestic and international clinical vendors and study sites. You will collaborate with Clinical Operations to design company-wide SOPs that reinforce consistent GCP compliance. You will coordinate with Regulatory Affairs, Clinical Operations, Clinical Development, Pharmacovigilance, and Translational Sciences on compliance matters and regulatory inspections.

Requirements

You hold a Bachelor of Science or Bachelor of Arts degree in a scientific discipline or equivalent hands-on experience. You bring three to five years of focused clinical quality assurance experience within biopharmaceutical or CRO environments. You possess a strong understanding of global GCP, GCLP, and GVP regulations and how these standards apply to clinical trials and safety functions. You can interpret regulations and translate them into practical guidance for internal teams and external vendors. You have managed end-to-end audit lifecycles, including planning, execution, findings, and corrective action tracking. You are experienced working within Quality Management System infrastructure and adapting processes under a Quality Manual. You can oversee the design and delivery of GCP, GCLP, and GVP training for clinical personnel. You communicate clearly with senior leadership during inspections and support site and vendor readiness.

Responsibilities

You will assure that Coherus GCP, GCLP, and GVP systems and records comply with global regulatory requirements. You will partner at a senior level with the Head of Quality to ensure globally aligned, timely, and regulatory-compliant audit and inspection responses while driving clear accountability and ownership among functional heads of Clinical Operations and Pharmacovigilance. You will work hands-on within the Coherus Quality Management System infrastructure and systems, adapting and owning process development under the Coherus Quality Manual. You will provide quality oversight for the development, closure, review, approval, and management of PV-related CAPAs and audit findings, ensuring strategic remediation, risk mitigation, and sustainable quality improvements across the PV system. You will represent Clinical Quality on internal project teams. You will represent Coherus Clinical Quality to external Quality counterparts such as CROs and bioanalytical laboratories. You will assess compliance risk areas and work with affected parties to develop and maintain internal Clinical risk management procedures. You will oversee the planning, conduct, and closure of GCP, GCLP, and GVP compliance audits internationally and domestically. You will oversee the clinical vendor audit program. You will work closely with the Head of Clinical Operations to design and implement company-wide GCP compliance SOPs. You will partner with Clinical stakeholders, including Regulatory Affairs, Clinical Operations, Clinical Development, Pharmacovigilance, and Translational Sciences regarding GCP, GCLP, and GVP compliance issues. You will provide guidance, interpretation, and information on GCP, GCLP, and GVP regulations, standards, and quality systems. You will play a lead role in regulatory inspections and coordinate responses to resolve findings alongside respective functional leaders. Along with Clinical Operations, you will support clinical sites and vendors during regulatory inspections that include Coherus studies and related activities. You will oversee and facilitate GCP, GCLP, and GVP training for functional areas and develop appropriate training for personnel involved in clinical trial execution. You will support due diligence activities as relevant. You will prepare and manage the annual CQA budget. You will maintain the audit universe and develop and plan for clinical trial and post-marketing activities. You will review and sign all associated policies, procedures, plans, memorandums, and deviation records as a Quality reviewer and approver.