Site Quality Leader — GMP, Compliance & Strategy

Crispr Therapeutics AG; Framingham (MA); Hybrid; USD 230,000 - 250,000; Full time

Job summary

CRISPR Therapeutics AG in Framingham, MA seeks a Quality Site Head to lead the Quality function for our internal manufacturing facility. You will drive a culture of quality, compliance, and continuous improvement, ensuring GMP standards are met across manufacturing, testing, and lifecycle management.

This role combines strategic oversight with hands-on execution. The ideal candidate has 15–20+ years in biopharma QA, deep regulatory knowledge, and proven experience hosting Health Authority

Qualifications

• BS/MS in Life Sciences with 15–20+ years in biopharmaceutical QA at a GMP manufacturing facility.
• Experience with FDA/EMA/ICH regulations and guidelines.
• Experience hosting Health Authority inspections.
• Strong leadership, mentoring, and people-management skills.

Responsibilities

• Provide strategic direction and operational leadership for the site Quality function.
• Oversee end-to-end Quality within the site including GMP compliance, materials management, batch review, change control, and exceptions.
• Ensure product disposition aligns with GMP and regulatory submissions.
• Establish quality metrics to demonstrate adherence to regulations and procedures.
• Collaborate with internal partners to enable compliant manufacturing and lifecycle management.
• Lead site inspection readiness and host audits and Health Authority inspections.

Skills

GMP QA leadership

Regulatory knowledge

Quality Assurance

Cross-functional collaboration

Education

BS/MS in Life Sciences

PhD in Life Sciences

Job description

CRISPR Therapeutics AG in Framingham, MA seeks a Quality Site Head to lead the Quality function for our internal manufacturing facility. You will drive a culture of quality, compliance, and continuous improvement, ensuring GMP standards are met across manufacturing, testing, and lifecycle management.

This role combines strategic oversight with hands-on execution. The ideal candidate has 15–20+ years in biopharma QA, deep regulatory knowledge, and proven experience hosting Health Authority