Senior Manager, Clinical Quality Assurance

Company Overview

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 partnerships 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 in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.

Position Summary

This position will support quality assurance activities related to GLP and GCP for clinical development at CRISPR, its CRO’s, laboratories and Investigator sites.  The Sr. Manager will collaborate with internal and external stakeholders as the Quality Assurance representative on clinical teams, providing QA guidance regarding global Health Authority Regulations and working to instill a quality culture within CRISPR Therapeutics.

Responsibilities

• Participate and actively engage in strategic initiatives which require GLP quality support
• Provides continued development and guidance of administration programs to promote and monitor the quality and performance of operations as they relate to nonclinical and pharmacological studies
• Review/audit study materials, data and reports associated with nonclinical, pharmacological, and regulatory submissions
• Assist and advise in the development of CAPA plans, implementation, and follow-up
• Support GLP vendor, study, and process audits
• Develop SOP’s and operational tools to assist with oversight and demonstrating compliance with applicable regulations
• Contribute to the continuing development of a quality culture at CRISPR
• Ability to manage multiple studies/projects and to collaborate effectively in a dynamic, cross-functional matrix environment

Minimum Qualifications

• BS/BA with 8 to 10 years of experience in pharmaceutical / biotech industry with experience in the GLP/GCLP environment
• Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for GLP/GCLP
• Practical knowledge of GLP/GCLP related audits activities and business standards
• Demonstrated knowledge and/or prior experience in Quality Assurance

Preferred Qualifications

• Five or more years in a GLP QA regulated role
• Prior experience with nonclinical studies and CRO oversight
• Experience in Cell and Gene Therapy

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, 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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