CRISPR Therapeutics Senior Specialist/Manager, Quality Management Systems in Cambridge, Massachusetts
CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.
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.
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
Manager: A minimum of 8 years? experience in related Biopharmaceutical QMS roles.
Specialist: 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
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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