Head of QA & GMP Compliance for Biotech Therapies

Aspect Biosystems; Colorado; On-site; USD 191,000 - 202,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits package

Support for continuous learning and career progression

Job summary

Aspect Biosystems is seeking a Head of Quality Assurance to lead the QA team within its technical operations in Colorado. The role involves establishing a GMP compliant Quality Management System and ensuring GxP compliance across bioprinted tissue therapeutics.

The ideal candidate will have over 10 years of experience in Quality Assurance leadership in a biotech environment and a strong understanding of regulatory guidelines. The position offers a competitive salary range of $191,000 - $202,000, plus benefits including equity and support for career development.

Qualifications

• 10+ years of progressive Quality Assurance leadership experience.
• Expert understanding of FDA, EMA, and Health Canada regulations.
• Demonstrated success in phase-appropriate QMS design.

Responsibilities

• Establish and maintain a GMP compliant Quality Management System.
• Lead inspection readiness activities and host regulatory inspections.
• Build and lead a high-performing QA team.

Skills

Quality Assurance leadership

GMP compliance

Regulatory guidelines expertise

Team leadership

Quality Management System design

Education

Bachelor’s, Master’s, or Ph.D. in Life Sciences

Job description

Aspect Biosystems is seeking a Head of Quality Assurance to lead the QA team within its technical operations in Colorado. The role involves establishing a GMP compliant Quality Management System and ensuring GxP compliance across bioprinted tissue therapeutics.

The ideal candidate will have over 10 years of experience in Quality Assurance leadership in a biotech environment and a strong understanding of regulatory guidelines. The position offers a competitive salary range of $191,000 - $202,000, plus benefits including equity and support for career development.