Director, Clinical Quality Assurance (CQA)

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 internal project teams
• Represent Coherus Clinical Quality to external (e.g. CRO, bioanalytical laboratory) Quality counterparts
• Assess GCP, GCLP, and GVP compliance risk areas and work with the affected parties to develop and maintain internal Clinical risk management procedures
• Oversee the planning, conduct, and closure of GCP, GCLP, and GVP compliance audits (international and domestic)
• Oversee clinical vendor audit program
• Work closely with the Head of Clinical Operations to design and implement company-wide GCP compliance SOPs
• Partner with Clinical stakeholders, including Regulatory Affairs, Clinical Operations, Clinical Development, Pharmacovigilance, and Translational Sciences, regarding GCP, GCLP, and GVP compliance issues
• Provide guidance, interpretation and information on GCP, GCLP, and GVP regulations, standards and quality systems
• Play a leadrole in regulatory inspections and the coordination of responses to resolve findings along with the respective functional leaders
• Along with Clinical Operations, support clinical sites and vendors during regulatory inspections that include Coherus studies and/or activities
• Oversee and facilitate GCP, GCLP, and GVP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials.
• Support due diligence activities as and where relevant
• Prepare and manage the annual CQA budget
• Maintain audit universe and develop and plan for clinical trial and post-marketing activities.
• Review and sign all associated policies, procedures, plans, memorandums, deviation records as a Quality reviewer and approver.

Qualifications:

• BS/BA degree in scientific discipline from an accredited college or university or equivalent experience
• 6-8 years or greater experience in clinical quality assurance roles, including experience working in a small pharmaceutical/ biotech company
• In-depth knowledge of and ability to interpret and apply GCP, GCLP, EU, FDA and ICH regulations and guidelines
• Experience in planning and conducting GCP audits as Lead Auditor
• Experience hosting regulatory inspections and managing inspection readiness activities
• Experience with Quality Management Systems (e.g. documentation and records management, change control, deviations, investigations, training, and CAPA programs)
• Strong critical thinking and decision making skills
• Must be able to work in a fast paced and highly expert environment
• Excellent interpersonal and written communication skills
• Excellent collaboration skills
• Ability to work independently, take accountability and work hands on to complete tasks in an active, direct, and practical manner
• Must be solution oriented and team focused
• Ability to travel up to 25% time