Quality Site Leader — GMP & Compliance

Crispr-Therapeutics-1; Framingham (MA); On-site; USD 230,000 - 250,000; Full time

Benefits offered by this job

Bonus

Equity

Benefits

Job summary

CRISPR Therapeutics, Inc. is recruiting a Quality Site Head to oversee the Quality function at its internal manufacturing site. You will drive a culture of quality, oversee GMP-compliant operations, and prepare for Health Authority inspections to ensure product disposition and compliant manufacturing processes.

The role requires 15-20+ years in biopharma QA, deep regulatory knowledge, and a proven track record in leading high-performing QA teams in GMP environments. On-site presence in the U.S.

Qualifications

• BS/MS in relevant scientific discipline and 15-20+ years in biopharmaceutical QA.
• Expertise in FDA/EMA/ICH regulations and product development lifecycle.
• Ability to operate strategically and hands-on in a GMP environment; inclusive leadership.

Responsibilities

• Provide strategic direction and operational leadership for the site Quality function at CRISPR’s internal manufacturing facility.
• Lead end-to-end Quality, including FUSE qualification/validation, materials management, batch record reviews, change control, and exceptions.
• Establish quality metrics to demonstrate adherence to GMP regulations and company procedures.
• Collaborate with internal partners to enable compliant and successful manufacturing (e.g., technology transfers, validation, testing, lifecycle management).
• Lead site inspection readiness, host audits and Health Authority inspections.

Skills

Quality Assurance

GMP Compliance

Regulatory Knowledge

Leadership

Audits & Inspections

Education

BS/MS in relevant scientific discipline

PhD preferred

Job description

CRISPR Therapeutics, Inc. is recruiting a Quality Site Head to oversee the Quality function at its internal manufacturing site. You will drive a culture of quality, oversee GMP-compliant operations, and prepare for Health Authority inspections to ensure product disposition and compliant manufacturing processes.

The role requires 15-20+ years in biopharma QA, deep regulatory knowledge, and a proven track record in leading high-performing QA teams in GMP environments. On-site presence in the U.S.