Director, Clinical Quality Assurance (CQA)

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 functional 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 produce 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
• Able 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

Pay

The Base Salary Range for this position is $190,000 to $240,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.