GMP Quality Site Leader — Gene Therapy Manufacturing

Crispr Therapeutics Inc; Framingham (MA); On-site; USD 230,000 - 260,000; Full time

Benefits offered by this job

Equity

Bonus

Benefits

Job summary

CRISPR Therapeutics Inc. is seeking a Quality Site Head to lead the Quality function at the internal manufacturing site and guide QA strategy across operations in Boston-based facilities.

The role emphasizes excellence in GMP manufacturing, regulatory readiness, and continuous improvement to support transformative gene-based therapies. The position requires extensive QA leadership experience in GMP biopharma, with a focus on inspections, life-cycle management, and cross-functional collaboration

Qualifications

• BS/MS in relevant scientific discipline with 15–20+ years in biopharma QA at GMP facilities.
• Deep knowledge of FDA/EMA/ICH regulations and product development lifecycle.
• Ability to operate strategically and hands-on within GMP environments.

Responsibilities

• Foster a Quality culture emphasizing innovation, improvement, and accountability.
• Provide strategic direction and operational leadership for site Quality and QA at the facility.
• Oversee end-to-end Quality activities including FUSE qualification/validation, materials management, batch record reviews, change control, and exceptions.
• Ensure Product Disposition aligns with GMP and regulatory submissions.
• Establish quality metrics to demonstrate GMP adherence and CRISPR procedures.
• Collaborate with partners to enable compliant manufacturing, tech transfers, validation, testing, and lifecycle management.
• Lead site inspection readiness and host Health Authority inspections.
• Coordinate with Quality Systems, Compliance, and External Quality Operations to advance GMP processes.
• Provide leadership to drive a fast-paced, learning culture; champion data-driven decisions.
• Promote a collaborative, transparent, ownership-focused work environment.

Skills

Quality Assurance

GMP Compliance

Leadership

Regulatory Experience

Cross-functional Collaboration

Inspection Readiness

Education

BS/MS in Life Sciences

Advanced degree (PhD)

Job description

CRISPR Therapeutics Inc. is seeking a Quality Site Head to lead the Quality function at the internal manufacturing site and guide QA strategy across operations in Boston-based facilities.

The role emphasizes excellence in GMP manufacturing, regulatory readiness, and continuous improvement to support transformative gene-based therapies. The position requires extensive QA leadership experience in GMP biopharma, with a focus on inspections, life-cycle management, and cross-functional collaboration