Associate Director, Quality Assurance (GMP QC Lab Oversight)

The Associate Director, Quality Assurance provides strategic and operational QA oversight of GMP Quality Control laboratory activities at the Camarillo site and reports to the Head of QA Operations. This role requires a regular on-site presence to effectively support daily GMP QC laboratory operations.

Key responsibilities include ensuring compliant laboratory operations through oversight of laboratory systems, facilities, and the qualification and validation of instruments and equipment. The role is accountable for review and approval of Certificates of Analysis (CoAs) and other GMP documentation, supporting laboratory investigations and batch disposition decisions, and contributing to Quality Management Review processes. The Associate Director also serves as a key partner to QC in driving inspection readiness, continuous improvement, and sustained GMP compliance.

• →Bachelor’s degree in a scientific discipline (or equivalent experience) with a minimum of 8 years of direct experience supporting GMP QC laboratory operations in a regulated pharmaceutical or biotechnology environment, including QA oversight.
• →Demonstrated experience in biologics/protein therapeutics, including manufacturing and testing of drug substance, drug product, and finished goods.
• →Demonstrated experience handling QC-related issues, records, and laboratory operations, including analytical documentation, deviations, and investigations, within a GMP environment; prior hands-on QC laboratory experience strongly preferred.
• →Experience reviewing and approving equipment and instrument qualification and validation documentation (e.g., IQ/OQ/PQ), with working knowledge of lifecycle management principles; experience applying risk-based approaches to computerized systems (GAMP 5) preferred.
• →Strong working knowledge of FDA cGMP regulations and ICH guidelines applicable to QC laboratory operations.
• →Experience leading and/or overseeing laboratory investigations, including OOS, OOT, deviations, CAPAs, change control, and data integrity events within a GMP environment.
• →Solid understanding of CoA/CoT generation and approval, and experience supporting batch disposition decisions in a GMP setting.
• →Demonstrated experience supporting internal audits, external audits, and regulatory inspections, including inspection readiness and response activities.
• →Strong written, verbal, and interpersonal communication skills, with the ability to effectively influence cross-functional teams.
• →Proven ability to exercise sound judgment, prioritize effectively, and operate successfully in a fast-paced, on-site GMP environment.

• On-site presence in Camarillo is required to support daily GMP QC laboratory operations.
• Up to 20% travel may be required to support audits, external laboratories, or business needs.

The Base Salary Range for this position is $170,000 to $200,000. 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.