Director, Quality Assurance

Summary

Cartesian Therapeutics, a fully integrated, clinical stage biopharmaceutical company pioneering RNA cell therapy, is currently seeking a Director of Quality Assurance with extensive experience in biopharmaceutical Quality Assurance and management of quality programs for clinical cell therapy assets.

This position will report directly to Cartesian's Vice President of Quality. The ideal candidate will be a highly motivated professional who can lead Cartesian's Quality Assurance operations. The role is primarily QA-focused with other broad responsibilities in 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 environments, with knowledge of ICH guidelines and FDA compliance for investigational cell therapy products.

Principal Duties/Responsibilities:
· MS with 5+ years' experience or PhD with 2-5 years' experience in biopharmaceutical quality control or Quality Assurance in positions of increasing responsibility
· Supervise the daily operations of the Quality Assurance team. Mentor and train the members of the QA staff.
· Manage and improve upon current quality systems for IND enabling functions
· Manage lot release with the Director of Quality Control and external partners
· Manage quality systems such as document control, change control, deviation, CAPA systems, and management review
· Supervise inventory management
· Supervise the facility and equipment maintenance
· Manage the auditing activities for all suppliers, contract CROs, CMOs, outside testing laboratories, and internal operations
· Provide leadership and guidance during regulatory submissions and inspections
· Author, review, and/or approve SOPs/policies and technical reports with general guidance
· Lead investigations (Deviations, IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with minimal guidance as required
· Lead, author, perform, and/or review qualification and validation activities for Manufacturing and Quality Control in collaboration with the Directors of Manufacturing and Quality Control
· Author/co-author trending reports and quality reviews to senior management on key performance indicators under Cartesian's QMS

Qualifications:
· A bachelor's degree or higher in a relevant scientific discipline
· At least 10 years of experience in Quality Assurance in the biopharmaceutical industry, with increasing responsibilities and leadership roles (Ideal candidate will have prior experience in cell therapy Quality Assurance)
· In-depth knowledge of current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and other applicable regulations and standards
· Experience in conducting and hosting internal and external audits and inspections
· Experience in developing, implementing, and maintaining quality systems and procedures
· Excellent communication, interpersonal, and problem-solving skills
· Ability to work independently and as part of a cross-functional team

Work Environment:

We offer a dynamic, intellectual environment with amenities including:

· High tech office setting

· Free snacks and beverages

· On-site gym

· Social, game, and relaxation areas

· Electric vehicle charging

Depending 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.