Director of Quality Assurance, GMP

Company: Caribou Biosciences, Inc.
Location: Berkeley
Posted on: March 14, 2023

Job Description:

Caribou is a leading clinical-stage CRISPR genome-editing biopharmaceutical company founded by pioneers in this field. Leveraging our proprietary technologies, we are developing genome-edited, off-the-shelf immune cell therapies for the treatment of patients with devastating human diseases, including cancer. We believe that cell therapies are critical now and for the future of cancer therapeutics, and that advanced genome editing is necessary to develop sophisticated cell therapies to treat a variety of malignancies. We are developing a pipeline of wholly-owned, genome-edited, off-the-shelf CAR-T and CAR-NK cell therapy product candidates for a range of tumor types. Caribou's headquarters are in Berkeley, California.
Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, their contributions are recognized, and their needs are met.
Caribou Biosciences is seeking a Director of Quality Assurance, GMP. 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 othervendors to support Caribou's manufacturing and testing 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.
Responsibilities:

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• 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 and critical raw materials, drug substance, drug product, and / or finished goods
  
• Ensure Caribou's TechOps (CMC) and quality vendor activities are compliant with cGMP, 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, etc.
  
• Train and mentor 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 and critical raw materials, drug substance, drug product, and label and packaging, including analytical testing, stability, sample retention, and distribution
  
• Experience as or acts as the QA Veeva System Owner and Subject Matter Expert for Veeva QualityDocs, Veeva Training and Veeva QMS. Gatekeeper for Veeva system access and develops and leads Instructor Lead Training for Veeva Applications. Resolves Veeva System problems and identified areas for improvement. Communicates Veeva application changes.
  
  Candidate must possess:
  
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  • 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 andsterile 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 compensation and benefits include:
    
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    • Comprehensive compensation package, which includes stock options and an employee stock purchase program for all employees
      
    • Salary range: $210K to $250K - This represents the present low and high end of the Company's pay range for this position. Actual pay will vary based on various factors, including but limited to location, skill, experience, and performance
      
    • Generous paid vacation time, in addition to company-observed holidays and floating holidays
      
    • Excellent medical, dental, and vision insurance
      
    • 401(k) retirement savings plan, which includes matching employer contributions
      
    • Tuition reimbursement program
      
      The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.
      Caribou is an equal opportunity employer and does not discriminate based on 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. Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
      Caribou requires employees to be fully vaccinated, including a booster shot, against COVID-19 unless they have an approved medical or religiousaccommodation.Proofof such vaccination will be required as part of the hiring process.
      For more information about Caribou, visit www.cariboubio.com and 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.
      

Keywords: Caribou Biosciences, Inc., Berkeley , Director of Quality Assurance, GMP, Executive , Berkeley, California