Director, Clinical Quality Assurance (CQA)

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.

• →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

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.

Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.