Senior Manager, Quality Management Systems

Job Description:

Company Overview

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.

Position Summary

This position will be responsible for building, managing, and administering CRISPR’s Quality Management System, specifically the Deviation, Change Control and CAPA processes. The candidate will administer Kivo QMS and will ensure compliance with established procedures. Enhancement of existing procedures, and creation of new best practices will be a critical component of this role.

Responsibilities

• Lead the QMS Program, specifically the deviation, CAPA, & change control programs
• Develop, improve, and administer the QMS Program
• Act as Kivo QMS business administrator
• Provide subject matter expertise to improve the QMS
• Develop and improve Quality department procedures
• Train new users on Kivo QMS
• Ensure compliance with approved CRISPR procedures as they relate to the creation and approval of QMS records
• Coordinate periodic review of QMS records
• Generate metrics to ensure on-time record closure and identify corrective actions
• Develop and present QMS metrics to management
• Create best practices for authoring technical investigations, root cause analysis tools, and corrective and preventive actions
• Meet with QMS record owners and participants to ensure proper system usage
• Support internal and external audits related to the QMS
• Enhance the Quality Culture by being a proactive and professional resource for the business.

Minimum Qualifications

• Minimum of 10+ years’ experience in related Biopharmaceutical QMS roles
• Experience in Biopharmaceutical QA and/or Quality System improvement roles is preferred
• BA or BS is preferred though long-time experience in QA may be acceptable
• Strong organizational skills and attention to detail
• Strong interpersonal skills
• Computer skills and previous experience with eQMS
• Ability to provide subject matter expertise regarding QMS implementation and administration
• Systems Administration experience

Preferred Qualifications

• MS or advanced degree
• Experience with Gene Therapy / Cell Therapy products
• Previous experience with Kivo QMS
• Computer System validation experience
• Entrepreneurial and results driven
• Project Management experience
• MS Office proficiency

Competencies

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit – Proactive. Ownership mindset

CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy