Head of Quality Assurance

SummaryCartesian Therapeutics, a fully integrated, clinical stage biopharmaceutical company pioneering RNA cell therapy, is currently seeking a Head of Quality Assurance with extensive experience in biopharmaceutical quality assurance and management of quality programs for clinical cell therapy assets.The ideal candidate will be a highly motivated professional who can lead Cartesian's Quality Assurance operations. The Head of QA will oversee quality for all GxP operations at Cartesian, a fast-paced cell therapy environment. The candidate should embrace a collaborative work environment and be able to execute multiple projects concurrently. This position is ideal for candidates with experience in GLP/cGMP/GCP environments, with knowledge of ICH guidelines and FDA compliance for investigational cell therapy products.Principal Duties/ResponsibilitiesSupervise the daily operations of the Quality Assurance team. Mentor and train the members of the QA staff.Oversee the implementation, execution, and continuous improvement of Cartesian's Quality Management SystemOversee lot release processes with the Director of Quality Control and external partnersOversee quality systems such as document control, change control, deviation, CAPA systems, and management reviewOversee the auditing activities for all suppliers, contract CROs, CMOs, outside testing laboratories, and internal operationsProvide leadership during regulatory submissions and inspections Author, review, and/or approve SOPs/policies and technical reports with general guidanceLead investigations (Deviations, IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with minimal guidance as requiredSupport qualification and validation activities for Manufacturing and Quality Control in collaboration with the senior Manufacturing, Quality Control, and Validation leadersAuthor/co-author trending reports and quality reviews to senior management on key performance indicators under Cartesian's QMS.QualificationsBS with 10+, MS with 5+ or PhD with 2-5 years' leadership experience in biopharmaceutical quality assurance and clinical quality assurance.In-depth knowledge of current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and other applicable regulations and standardsExperience in conducting and hosting internal and external audits and inspectionsExperience in developing, implementing, and maintaining quality systems and proceduresExcellent leadership, communication, interpersonal, and problem-solving skillsAbility to work independently and as part of a cross-functional teamWork EnvironmentWe offer a dynamic, intellectual environment with amenities including:High tech office settingFree snacks and beveragesOn-site gymSocial, game, and relaxation areasElectric vehicle chargingDepending on expertise this position may require occasional hands-on work (e.g., to train others) in an R&D laboratory setting. In these instances, employees work in an environment in which safety, environmental, and health concerns require strict adherence to Cartesian's policies, rules and regulations. This includes use of appropriate safety and personal protective equipment.Cartesian is an Equal Opportunity Employer and is committed to fostering an environment in which all employees are treated fairly without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, ancestry, disability, marital status, genetic information, military status, or any other characteristic protected under applicable law.