Quality Site Head

CRISPR Therapeutics•Framingham, MA

6d•$230,000 - $250,000•Onsite

About The Position

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.

Requirements

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
Direct experience hosting Health Authority inspections
Demonstrated ability to mentor staff and build an effective Quality team
Self-awareness, integrity, judgment, and ability to remain calm and consistent under pressure
Role model for Quality mindset, as well as the CRISPR CUREs values (Collaboration, Undaunted, Results Oriented, Entrepreneurial)
Ability to execute and follow-through to completion.
Strong leadership and an innate ability to collaborate and build relationships is critical.

Nice To Haves

Prior experience in the manufacture of cell and gene therapy products
Progressive Quality Control and/or Analytical Sciences experience, including method transfer, validation and routine release and stability testing operations
Advanced degree such as PhD in Life Sciences or a related field

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 culture.
Be a champion of a highly collaborative, transparent, data driven, make it happen’ culture.