Manager, Quality Assurance, Stability
About the position Vaxcyte is seeking a QA Manager who will serve as the Quality Assurance representative overseeing Vaxcyte's stability program for our products. The responsibilities include, but are not limited to, reviewing and approving stability protocols, reports, data, and expiry/retest records, providing QA oversight of the stability studies conducted at Contract Manufacturing Organizations (CMOs) and Contract Testing Labs (CTLs), and managing Stability documents in Veeva. The QA Manager will also manage change controls, deviations, and CAPAs related to stability. Responsibilities • QA Representative for quality management of the stability studies for Vaxcyte products. • Key participant in quality team focused on the oversight of stability studies at CMOs and CTLs. • Review and approval of stability protocols and reports. • Review and approval of stability data and release data, as required. • Review and approval of expiry and retest documentation for Vaxcyte products. • QA representative for change controls, deviations and CAPAs associated with the stability program. • Work closely with Stability, Project Management team, other functional areas, and external vendors for management of routing, revisions, approval, and filing of Stability documents in Veeva (electronic document control system) within defined timelines. • Develop, implement and maintain procedures and policies. • Support process improvement initiatives. • Review and assess temperature excursions. • Represent QA at internal and external cross functional tactical team meetings. • Interact with key stakeholders to develop solutions to complex issues. • Promote a quality mindset and quality excellence approach to all activities. • May participate in compliance audits as required. • Escalate issues impacting the safety, efficacy and shelf-life of stability material to appropriate management. Requirements • BS or BA with minimum 5 years of relevant industry experience. Other combinations of education and/or experience may be considered. • Demonstrate in-depth knowledge of GMPs, FDA regulations and ICH guidelines. • Knowledge in both clinical and commercial product desired. • Demonstrate excellent verbal, written, and interpersonal communication skills, collaborative approach essential. • Demonstrate experience leading and contributing through influence and working in cross functional teams. • Experience working with Contract Manufacturing Organizations. • Strong sense of ownership for areas of responsibilities. • Knowledge of JPM, NovaStability and Veeva is desired. Benefits • Comprehensive benefits package • Equity component Apply tot his job