Title: Associate Director, Quality Assurance (GMP QC Lab Oversight)
Reports to: Head of Quality Assurance Operations
Location: Camarillo, CA (On-site)
Classification: Exempt
Overview: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.
Responsibilities:
- Provide QA oversight of GMP QC laboratory operations to ensure compliance with cGMP, FDA, and ICH requirements.
- Oversee QC laboratory systems, instruments, and equipment throughout their lifecycle, ensuring they remain in a validated and inspection-ready state.
- Review and approve QC-related GMP documentation, including analytical records, CoAs/CoTs, method qualification and validation reports, stability data, deviations, CAPAs, and change controls.
- Lead and oversee laboratory investigations (e.g., OOS, OOT, deviations, and data integrity events), ensuring robust root cause analysis, appropriate impact assessment, and timely, compliant resolution.
- Support batch disposition by ensuring QC data, CoAs, investigations, and associated documentation are complete, accurate, and compliant with internal procedures and regulatory expectations.
- Partner cross-functionally with QC, Manufacturing, Regulatory, and site leadership to ensure compliant laboratory operations, drive continuous improvement, and maintain sustained inspection readiness.
- Provide QA support and oversight for method transfer, validation, and technical transfer activities impacting QC laboratory operations.
- Collaborate with Facilities, IT, and QC to support equipment implementation, qualification, maintenance, and resolution of operational issues impacting GMP laboratory activities.
- Support and participate in internal audits, external audits, and regulatory inspections; contribute to inspection readiness activities and timely, effective responses.
- Contribute to Quality Management Review processes (e.g., QMR, PQR/APQR), including analysis of QC performance metrics, identification of quality trends, and execution of continuous improvement actions.
- Escalate significant quality risks and critical issues to the Head of Quality Assurance and senior leadership, as appropriate.
- Drive development, enhancement, and continuous improvement of SOPs, QA processes, and QC-related quality systems.
Qualifications:- 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.
Additional requirements- 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.
