Our RESETTM clinical trials with CABA-201 (investigational CD19-CAR T cell therapy) in lupus and myositis are now recruiting.

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Director, Quality Assurance Operations

Philadelphia, PA

About the Position

Reporting to the VP, Quality and Compliance, the Director, Quality Assurance Operations will provide quality oversight of production activities for Cabaletta Bio’s CAART and CART GMP manufacturing. This includes supporting and approving manufacturing investigations and ownership over GMP quality projects. This position leads quality activities at Cabaletta’s manufacturing partners. As primary GMP QA representative for the Cabaletta laboratories, this position will provide routine on-site guidance to laboratory personnel.

Responsibilities Include

  • Serve as the quality support for cell therapy manufacturing at CMOs and direct point of contact.
  • Provide management of compliance activities for site quality operations in accordance with Cabaletta SOPs and cGMPs.
  • Ensure CMC laboratory equipment, processes and analytical methods are qualified as appropriate
  • Perform lot release of clinical materials.
  • Participate in Quality and Compliance planning and management meetings.
  • Develop and deliver regulatory required GMP training as required.
  • Review, comment, and approve (as appropriate) GMP related documents such as protocols, deviation investigations, change controls, CAPAs, reports, etc.
  • Perform or assist with CDMO and CTL quality investigations.
  • Perform or assist with product complaint investigations.
  • Support regulatory and conduct audits by ensuring inspection readiness within Cabaletta laboratories
  • Function as the VP, Quality and Compliance’s delegated backup when necessary.

Required Qualifications

  • Minimum of a Bachelor’s degree in a scientific discipline or equivalent.
  • 10+ years’ experience in biotech/pharma, including demonstrated increasing levels of responsibilities; leadership experience a plus.
  • At least 5 years related QA/QC experience, preferably in cell or gene therapy
  • Strong interpersonal, communication, teamwork, and analytical skills.
  • Highly proficient in Microsoft Word, Excel, and PowerPoint.
  • Strong working knowledge of cGMPs with knowledge of GLPs a plus.
  • Detail oriented with strong analytical and organization skills.
  • Ability to manage multiple tasks, establish priorities and work independently.
  • Strong team orientation and passion for continuous self-development.
  • Experience in industry or in a startup industrial setting is preferred.

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How to Apply

Please click the link at the bottom of the posting to submit an application.

Benefits

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.