Director of Quality Assurance

170 - Regulatory Affairs · Berkeley, California
Department 170 - Regulatory Affairs
Employment Type Full-Time
Minimum Experience Executive

Caribou Biosciences, Inc. is a leading clinical-stage CRISPR genome editing biotechnology company located in Berkeley, CA. Caribou's tools and technologies provide transformative capabilities to therapeutic development and the company is advancing an internal pipeline of genome-edited cell therapies for various oncology indications. Caribou was founded in 2011 by CRISPR pioneers including Nobel Prize winner Jennifer Doudna, PhD, Martin Jinek, PhD, and Rachel Haurwitz, PhD, our President and CEO. The eight-year-old company has developed a best-in-class CRISPR genome editing technology platform and has a leading intellectual property position.

 

At Caribou, every employee is valued for their unique perspective, background, and diversity. Every person on the Caribou team contributes to problem solving and innovation. The Company’s vision is to advance agile genome editing innovations for the benefit of our communities.

 

Caribou Biosciences is seeking a Director of Quality Assurance. The ideal candidate will be responsible for operational management and strategic planning of QA activities in product testing, manufacturing and release, and product distribution. This QA position will be key in the selection of Contract Development Manufacturing Organizations (CDMOs), CROs and other vendors to support Caribou's development needs. Primary responsibilities include establishment and maintenance of internal QA GxP systems, oversight of CDMOs / CTLs to ensure compliance with Caribou's needs as well as global regulatory requirements. This individual will work to continuously improve GxP quality processes and to support the state of GxP compliance at Caribou. The position will focus initially on GxP Quality build-out to strengthen early-stage Clinical-phase Quality Systems, ensuring that the systems and processes developed will accommodate future late-stage and commercial requirements. This is an exciting, interdisciplinary role for a highly qualified and motivated individual. This expertise, along with a diverse drug development background and the organizational and interpersonal skills required to build and foster strong relationships with collaborators, will be needed for success. This role will initially be remote, with the expectation that the position will be on-site in Berkeley sometime in 2021.

  

Responsibilities:

  • Independently provide QA oversight of GxP activities at Caribou and its CROs, CDMOs, CTLs, GMP storage and distribution vendors.
  • Develop and implement risk-based Quality strategies for investigational materials including establishment and maintenance of phase-appropriate quality systems; proactively identify and mitigate quality risks.
  • Responsible for QA-related activities and requirements to enable release of starting / critical raw materials, drug substance, drug product, and finished goods.
  • Ensure Caribou's TechOps (CMC), nonclinical and clinical vendor activities are compliant with cGMP, GLP, GCP, FDA, ICH, EMA regulations and guidelines and industry standards.
  • Lead strategic development, implementation, and maintenance of Quality Systems and SOPs related to GxP activities.
  • Lead QA-related investigations, including input and approval of plans for resolution of product-impacting Quality issues; provide oversight of appropriate CAPAs associated with investigations, deviations, product complaints and recalls.
  • Collaborate with TechOps (CMC), nonclinical, clinical and regulatory colleagues to establish metrics and report the state of QA and compliance of GxP vendors to senior management.
  • Stay abreast of industry developments – forthcoming regulations, guidance, best practices, and etc., training and mentoring staff on global GxP regulations and guidance.
  • Ensure routine regulatory inspection readiness to prepare for audits by global regulatory health authorities. 
  • Strong understanding of GMP Quality for starting / critical raw materials, drug substance, drug product, and label and packaging, including QC testing, stability, and distribution.  

 

Candidate must possess:

  • Minimum B.Sc. degree in Life Science field, advanced degree a strong benefit, and a minimum of 15 years of applicable pharmaceutical drug development experience with at least 10 years of Quality Assurance experience.
  • Useful background within a fast-paced, innovative, biotech start-up organization could include experience with biologics, critical starting materials, cell and gene therapy materials / reagents and sterile dosage drug products.
  • Strong working knowledge of global GxP requirements, regulations, and guidance; sound judgment and commitment to ethical conduct. Direct experience in successfully managing health authority Inspections, multiple projects and responsibilities concurrently.
  • Ability to work with multi-disciplinary teams and with individuals at all levels.
  • Ability and willingness to travel up to approximately 25% of the time.

 

Caribou Biosciences, Inc. is a dynamic start-up biotechnology company, and the successful candidate should have a passion for science and a desire to work in a collaborative environment. Caribou promotes a culture in which employees are respected and valued for hard work, innovation, personal initiative, and teamwork.

 

Caribou compensation and benefits:

  • Comprehensive compensation package including stock options
  • Generous paid vacation time in addition to Company-observed holidays
  • Excellent medical, dental, and vision insurance
  • 401(k) retirement savings plan including matching employer contributions
  • Tuition reimbursement program

 

For more information, please visit www.cariboubio.com. Caribou is on Twitter. Follow the Company @CaribouBio.

 

Caribou is an equal opportunity employer and does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.

 

Direct applicants only. No agencies please.

 

 

 

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  • Location
    Berkeley, California
  • Department
    170 - Regulatory Affairs
  • Employment Type
    Full-Time
  • Minimum Experience
    Executive