Quality Site Head

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 culture
• Be 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
• 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

Preferred Qualifications

• 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

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.