Director/Sr Director, Quality

At CARGO Therapeutics, upending the status quo is in our DNA. We combine a deep understanding of CAR T resistance with a vision of transforming peoples’ lives through the development of next generation cell therapies that provide deeper and more durable responses to a growing number of patients.

CARGO is an exciting biotechnology company founded by Crystal Mackall and Robbie Majzner out of Stanford to develop next generation CAR T cell therapies designed to achieve superior efficacy by pre-empting important drivers of drug resistance. Our lead program includes a differentiated and clinically validated CD22 CAR that is in clinical development for patients with B-cell malignancies. To help move this and other programs forward, CARGO has brought together a passionate and seasoned team to develop a focused portfolio strategy. Our team is based in San Mateo, California.

Join us to help make a difference.

Position Summary

CARGO is hiring a Director/Sr Director, CMC Quality Assurance within the CARGO technical Operations team.   The role will report to the CTO and work closely with the CARGO’s executive team, the CMC leadership team and across the entire team to develop the Quality function at CARGO.  Given that we are an early-stage company, we expect the Quality function to focus on the immediate needs to advance the portfolio into the clinic with a phase appropriate mindset.  Very importantly, this role is critical to setting the right tone for a strong quality focus and accountability across the entire company.  We expect the quality function to grow and evolve as the product and technology portfolio evolves along with our manufacturing strategy.  The initial scope of the role will focus on quality oversight of external manufacturing partners and CDMOs, installation of phase appropriate quality systems, supplier audits and quality oversight of internal CMC IND enabling activities.  The candidate is expected to play both in operational hands-on as well strategic capacity while we build the overall company.  It is an exciting opportunity for a qualified individual to come in at the ground floor and set the direction for quality function and overall strategy.  The candidate will work closely with other leaders in the CMC team (Head of External Manufacturing, Head of Process Sciences, Head of Gene Delivery and Editing, Future Head of Manufacturing and Supply Chain) as well as the CARGO clinical and research teams to ensure sound quality framework and oversight of our development and manufacturing operations.  The role is based in San Mateo, CA and may also be suitable for a hybrid work arrangement.

What You’ll Do at CARGO

The Head of QA is expected to build out the initial Quality function and strategy and execute against the strategy. 

  • The external QA part of the scope of this role will include quality oversight of 4-6 CDMO partners located in the US and Europe.  Work at the CDMO includes development of process and analytical methods, tech transfer in to the CDMOs (and potentially out back to CARGO or another CDMO in the future) in preparation for a registration enabling clinical trial for the lead asset.
  • Work with external consultants and internal team members to develop and install a phase appropriate quality system for CARGO’s portfolio, with the initial focus heavily on the lead CD22 asset headed towards a registration enabling trail.
  • Establish systems and procedures for various elements of quality needed for registration enabling trial including, supplier audits, lot disposition, deviation management, non-conformance batches, chain of identify, material and sample handling, lot testing and release, batch record reviews, tech transfers.
  • Ensure timely execution of the above-mentioned applicable quality procedures for the upcoming work packages related to tech transfers, GMP supply and batch release.
  • Actively participate in the CMC team.  Contribute to the development and execution of the product strategy.
  • Work with internal research counterparts and external academic partners to ensure appropriate quality oversight of incoming materials, documents, and data.
  • Provide quality oversight of the IND enabling documents
  • Conduct audits of the raw material suppliers, CDMOs and other external partners involved in the entire supply chain for our cell therapy portfolio.
  • Provide quality support to the clinical team in site activation and apheresis operations.
  • Author, review sections of the Module 3 content for IND and eventually BLA and global regulatory submissions.
  • Participate in the manufacturing site inspections of the external partners, as appropriate and per contract. Ensure inspection readiness in support of the regulatory submissions.
  • Establish appropriate electronic quality systems as the company scales the operations
  • Manage the quality oversight of the GMP training program for the employees
  • Oversee the development and implementation of innovative systems, tools and streamlined processes to create and maintain sound and phase appropriate quality system
  • Responsible for continuous improvement of quality systems and processes
  • Interface with external quality consultants and eventually hire additional quality professionals into the team

Experience and Qualifications

  • Undergraduate/graduate degree in life science or engineering.  Graduate degree not required, but preferred.
  • Minimum 10-15 years in biotech/pharma industry with 5+ years of Direct quality functional experience in a technical operations environment.  Of the total experience, candidate should have 5 plus years of experience managing direct teams.  3 years of experience in cell and gene therapy industry is highly desired in the context of the unique quality systems needed to support personalized treatments.
  • Previous experience with supplier audits, regulatory inspections, working with CDMOs and setting up scalable quality systems for early stage growing companies.
  • Authoring experience/familiarity with CMC content in regulatory submissions
  • Experience of having worked in cross functional product development teams
  • Knowledge of GMP and quality requirements for cell therapy products in the context of global approvals
  • Ability and interest in rolling up their sleeves to perform hands-on quality activities while simultaneously building the team to ensure successful scalability as the company grows
  • Demonstrated proficiencies in leading successful health authority meetings and interactions
  • Ability to influence without direct authority
  • Independently motivated, excellent in execution, detail oriented
  • Strong written and verbal communication skills, collaboration skills
  • Ability to make timely and sound quality decisions when faced with complex supply, compliance, technical and regulatory considerations
  • Understanding of the unique aspects cell therapy manufacturing process and technology
  • Proven experience in building a high performing team. You can recruit and develop top talent, motivate and empower a team, work cross-functionally, and delegate effectively.
  • Must be willing and available for periodic travel (domestic US and international) as needed.

EEO & Employment Eligibility

CARGO Therapeutics, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. CARGO Therapeutics, Inc. also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requires of applicable law.

CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at CARGO, and it applies regardless of whether the position is located at a CARGO site or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.