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Manager/Senior Manager, Quality Management Systems

At CRISPR Therapeutics, we are focused on developing transformative gene-based medicines for serious human diseases.We are rapidly translating our specific, efficient and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes and other diseasesOur multi-disciplinary team of world-class researchers and drug developers works every day to translate our CRISPR/Cas9 technology into breakthrough human therapeutics. Our lead program targeting the blood diseases β-thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.

Job 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 Veeva QMS for all users 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. This role may also assist in the administration and improvement of the CRISPR document and record management program.

Responsibilities

• Lead the QMS Program, specifically the deviation, CAPA, & change control programs

• Develop, improve, and administer the QMS Program

• Act as Veeva QMS business administrator

• Provide subject matter expertise to improve the QMS

• Develop and improve Quality department procedures

• Train new users on Veeva 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

• Assist in the administration of the CRISPR Document Control program and offer subject matter expertise

• Work to develop and imbue a Quality Culture

Minimum Qualifications

• A minimum of 5 years? experience in related Biopharmaceutical QMS roles.

• Experience in Biopharmaceutical QA and/or Quality System improvement roles is preferred.

• A 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

• Experience with Gene Therapy / Cell Therapy products

• Previous experience with Veeva QMS

• Veeva Administrator Certification

• Computer System validation experience

• Entrepreneurial and results driven

• Ability to work with little instruction

• Project Management experience

• MS Office proficiency

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.

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