Quality Site Head

Job Description:

Company Overview Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia.

CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, 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.

Position Summary Reporting to the Vice President, Head of Quality, the Quality Site Head will play a key leadership role both at CRISPR’s internal manufacturing site and within the Quality Assurance function as a whole. The ideal candidate will lead by example to promote excellence in every aspect of internal manufacturing operations as part of CRISPR’s mission to develop impactful therapies at the forefront of gene-editing technology.

Responsibilities Foster a Quality culture that values innovation, continuous improvement, and personal accountability

Provide strategic direction and operational leadership for the site Quality function at CRISPR’s internal manufacturing facility

Responsible for end-to-end Quality within the site, including FUSE qualification/validation, materials management, batch record reviews, change control, and exceptions

Responsible for Product Disposition ensuring that intermediates and drug products are manufactured and tested in accordance with GMP and regulatory submissions,Establish quality metrics to demonstrate adherence to GMP regulations and CRISPR procedures

Collaborate with internal partners to enable compliant and successful manufacturing (e.g. technology transfers, validation, testing, and lifecycle management)
Lead and maintain site inspection readiness, and host audits and Health Authority inspections

Work closely with Quality Systems and Compliance and External Quality Operations to advance all aspects of CRISPR’s GMP Quality processes

Provide leadership and management support for activities to drive a fast paced, highly efficient learning  a champion of a highly collaborative, transparent, data driven, make it happen’ culture.

Minimum Qualifications BS/MS in relevant scientific discipline and 15-20+ years of experience in a biopharmaceutical organization; including direct experience in Quality Assurance at a GMP manufacturing facility

Expertise in FDA/EMA/ICH regulations and guidelines and a strong understanding of pharmaceutical product development lifecycle are required

Able to simultaneously operate at both a strategic and hands-on level in a GMP environment

Inclusive leadership skills and keen organizational awareness, enabling the development of strong working relationships with colleagues regardless of job level or function

Ability to navigate a constantly evolving scientific and regulatory environment, and approach challenges with a proactive, ownership mindset

Dire…