Quality Systems Leader, GMP Biotech & Compliance

Artis BioSolutions; Watertown (MA); Hybrid; USD 170,000 - 230,000; Full time

Job summary

Artis BioSolutions seeks an Associate Director, Quality Systems to lead the strategy, design and continuous improvement of the Quality Management System supporting cell therapy, viral vector and fill-finish operations.

The role builds and leads the Quality Systems team, partnering with Technical Operations, Quality Control and Process Development to ensure compliance, risk-based decisions and right-first-time performance across the business.

Qualifications

• Minimum Bachelor's degree in STEM (biology, chemistry, engineering)
• 8+ years quality experience in GMP biotech manufacturing
• 5+ years leadership/management experience

Responsibilities

• Own strategy and continuous improvement of the Quality Management System from early clinical through late-stage development
• Lead audit readiness, supplier and client audits, and CAPA program
• Define and report quality metrics, risk management and decision making across Quality and operations

Skills

Quality Systems

Leadership

GMP knowledge

Risk Management

Education

Bachelor's degree in STEM

Tools

Veeva Vault

Job description

Artis BioSolutions seeks an Associate Director, Quality Systems to lead the strategy, design and continuous improvement of the Quality Management System supporting cell therapy, viral vector and fill-finish operations.

The role builds and leads the Quality Systems team, partnering with Technical Operations, Quality Control and Process Development to ensure compliance, risk-based decisions and right-first-time performance across the business.