Head of QA & Regulatory Compliance - Biotech

Aspect Biosystems; Fremont (CA); On-site; USD 191,000 - 202,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits package

Support for continuous learning

Job summary

Aspect Biosystems in Fremont, California is seeking a Head of Quality Assurance to lead the QA team and ensure compliance in bioprinted tissue therapeutics. You will establish a GMP compliant Quality Management System and oversee core QA functions while ensuring a culture of quality across the product value chain.

The ideal candidate has over 10 years of experience in Quality Assurance within the biotech industry and expertise in Cell/Gene Therapy. A competitive salary range of $191,000 - $202,000 annually is offered alongside a comprehensive benefits package.

Qualifications

• 10+ years of Quality Assurance experience in GMP environments.
• Expertise in regulatory guidelines and inspections.
• Proven track record in building QA teams.

Responsibilities

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

Skills

Quality Assurance Leadership

Regulatory Compliance

Team Building

GMP Compliance

Cell/Gene Therapy Expertise

Education

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

Job description

Aspect Biosystems in Fremont, California is seeking a Head of Quality Assurance to lead the QA team and ensure compliance in bioprinted tissue therapeutics. You will establish a GMP compliant Quality Management System and oversee core QA functions while ensuring a culture of quality across the product value chain.

The ideal candidate has over 10 years of experience in Quality Assurance within the biotech industry and expertise in Cell/Gene Therapy. A competitive salary range of $191,000 - $202,000 annually is offered alongside a comprehensive benefits package.