Vice President of Quality - Caribou Biosciences, Inc.

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve antitumor activity. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T and CAR-NK platforms as readily available treatments for patients with hematologic malignancies and solid tumors.

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, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.

We are seeking a Vice President of Quality who will lead the Caribou GxP Quality Organization and Operations while promoting a quality mentality culture. With responsibility for Quality Assurance, Quality Control, Quality Systems, & Clinical Quality, this key role will set the expectations and ensure delivery of a robust and balanced quality operations. In addition, this role will guide the development of phase appropriate systems, policies, and procedures to support early and late phase clinical, as well as commercial product quality and compliance. This role will report to the Chief Technology Officer and will be on-site or hybrid with at least 50% of the time at headquarters in Berkeley, CA.

Principal Duties and Responsibilities

• Lead the Quality Organization & Quality Culture for Caribou
• Develop a high-level Quality Strategy that maps out all the Quality components over time, with focus on rationale for how best to support the Caribou operations
• Develop the quality systems and processes needed to support Caribou
• Ensure appropriate oversite of the Caribou operation, with specific attention on GxP activities
• Oversee and manage quality for all internal activities as well as extensive network of external manufacturing and testing partners
• Collaborate closely with IT to establish systems strategy and plan, and ensure implementation
• Contribute and influence the senior leadership level of the Caribou organization beyond quality
• Mentor and coach quality staff to develop the skills and performance needed to succeed
• Key contributor to regulatory strategies and plans, especially with respect to CMC and clinical

Requirements (Skills, Education, Experience, etc.)

• Master's degree in technical field. Minimum of 15 years' experience in Biotech/Cell & Gene Therapy space
• Strong background in quality management, regulatory, compliance, quality systems, and quality operations supporting novel technologies
• Experience with US and EU CMC, regulatory & quality expectations, complex product development & operations activities, developing quality culture that balances all the competing factors
• Excellent people manager and cross-functional leader, able to lead diverse and complex teams with demonstrated success, and ability to influence up, down and across the organization to align quality expectations and corporate goals
• Demonstrated ability to lead and develop teams

Caribou compensation and benefits include:

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $300,000 to $350,000 - 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 not 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
• Employee stock purchase plan (ESPP)
• 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.

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