Director, Quality Assurance

Cartesian Therapeutics, a fully integrated, clinical stage biopharmaceutical company pioneering RNA cell therapy, is currently seeking a Quality Assurance Director 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 manage Cartesian's Quality Assurance operations. The Director 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 cGMP and GCP environments, with knowledge of ICH guidelines and FDA compliance for investigational late stage/commercial cell therapy products.

Key Responsibilities:

• Direct the daily operations of the Quality Assurance team. Mentor and train QA staff members.
• Oversee the implementation, execution, and continuous improvement of Cartesian's Quality Management System (QMS).
• Manage "quality on the floor" using real-time oversight.
• Foster a culture of teamwork and alignment.
• Oversee lot release processes with the Director of Quality Control and external partners.
• Oversee the external quality function, including auditing activities and quality agreements for suppliers, contract research organizations (CROs), contract manufacturing organizations (CMOs), and outside testing laboratories, using a risk-based strategy.
• Provide leadership during regulatory submissions and inspections.
• Author, review, and/or approve standard operating procedures (SOPs)/policies and technical reports with general guidance.
• Lead investigations (deviations, out-of-specification (OOS) results, customer complaints), performing assessments and authoring protocols/reports.
• Oversee qualification and validation activities for Manufacturing and Quality Control in collaboration with Manufacturing, Quality Control, and Validation personnel.
• Author/co-author trending reports and quality reviews for senior management on key performance indicators within Cartesian's QMS.
• Independently identify and resolve complex problems through quality risk management and sound decision-making skills. Manage conflict and confidently address challenging issues.
• Demonstrate a proven track record of developing and leading teams, both within and outside the organization.
• Initiate and develop strategic initiatives, translating them into tactical solutions. Develop strategies and negotiate senior management approval for their implementation through staff.
• Communicate professionally, both verbally and in writing, and effectively represent the function. Demonstrate strong listening skills, interpersonal savvy, and peer relations.
• Effectively present complex data and strategies to large groups.

Qualifications:

• BS with 10 years or MS/PhD degrees 6 years of leadership experience in biopharmaceutical quality assurance and clinical quality assurance.
• In-depth knowledge of current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and other applicable regulations and standards.
• Experience conducting and hosting internal and external audits and inspections.
• Experience developing, implementing, and maintaining quality systems and procedures.
• Excellent leadership, communication, interpersonal, and problem-solving skills.
• Ability to work independently and as part of a cross-functional team.
• Experience in cell therapy quality operations is highly preferred.
• Experience in late stage clinical/commercial.
• Experience leading health authority inspections preferred.

Work Environment:

We offer a dynamic, intellectual environment with amenities including:

• High tech office setting
• Free snacks and beverages
• Social, game, and relaxation areas

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 the use of appropriate safety and personal protective equipment.

Salary Notice:

At Cartesian Therapeutics, we are committed to transparency and equity in our compensation practices. The salary range for this position is $175,000 to $215,000 per year. Please note that the final salary will be determined based on several factors, including but not limited to years of experience, industry experience, education, and specific skills relevant to the role. We believe in rewarding our team members fairly and encourage open discussions about compensation throughout the hiring process.

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.