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Head of Quality Assurance

2 months ago

Gaithersburg, United States Cartesian Therapeutics Full time
Job DescriptionJob Description

Summary

Cartesian 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/Responsibilities:

  • Supervise 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 System
  • Oversee lot release processes with the Director of Quality Control and external partners
  • Oversee quality systems such as document control, change control, deviation, CAPA systems, and management review
  • Oversee the auditing activities for all suppliers, contract CROs, CMOs, outside testing laboratories, and internal operations
  • Provide leadership 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
  • Support qualification and validation activities for Manufacturing and Quality Control in collaboration with the senior Manufacturing, Quality Control, and Validation leaders
  • Author/co-author trending reports and quality reviews to senior management on key performance indicators under Cartesian's QMS.


Qualifications:

  • BS 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 standards
  • Experience in conducting and hosting internal and external audits and inspections
  • Experience in 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

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.


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.