Director, Quality Assurance Commercial Operations

Oversee quality operations associated with CymaBay’s Commercial Programs ensuring company adherence to current Good Manufacturing Practices (cGMPs), Good Documentation Practices, global (e.g., FDA, EMA, and PMDA) regulatory standards, and internal procedures and practices for manufacturing, testing and release activities of drug product in support of registration batch manufacturing, validation activities and commercial supply.

Responsibilities include, but are not limited to, managing, leading, and coordinating resolution of quality related issues at CDMO/CMOs, review of GMP change controls, QA lot disposition, compilation of trending reports, writing quality investigations and assistance with product complaints investigations.

• Provide QA review of regulatory documents in support of customer filings (i.e. NDA). Oversee data gathering, analysis and reporting of manufacturing data for Annual Product Reports (APRs) in support of customer filings. Participate in the negotiation of Quality Agreements.
• Assure effective systems, processes, validations, and controls are established and maintained to support commercial operations. Oversee implementation of ongoing verification activities to assure products are continuously manufactured right the first time.
• Assure timely issuance, resolution and closure of investigations (e.g. deviations, customer complaints), and CAPAs in response to supplier, manufacturing and/or laboratory discrepancies. Provide QA leadership to assure thorough root cause investigations and effective corrective actions to prevent recurrences. Collaborate with department leaders to identify effective corrective actions that meet regulatory requirements while maintaining organizational agility.
• Identify, communicate, and escalate quality and compliance risks. Provide direction for and participate in timely resolution, acting always with an appropriate sense of urgency.
• Interact and develop relationships with CDMO/CMOs and continuously improve all aspects of quality to achieve and sustain conformance to internal and external requirements.
• Ensure Independent QA review and approval of master and executed batch records, CoAs, and analytical test results. Ensure effective and reliable lot disposition and release activities for drug products within established timeframes to meet customer commitments.
• Track and trend quality metrics, analyze trends and identify and assure implementation of improvement initiatives. Assure functional metrics are reported to management.
• Ensure alignment with Quality Management Team
• Perform other duties, as assigned