Quality Systems Lead — GMP Biotech & Cell Therapy

Landmarkbio; Watertown (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Landmark Bio seeks an Associate Director, Quality Systems to lead the strategy and continuous improvement of the Quality Management System supporting cell therapy, viral vector and fill-finish operations. Own core QMS functions including documentation, changes, deviations, CAPA, training and risk management.

The role drives audit readiness, supplier and client audits, and the overall Quality culture to support scalable, compliant operations from early clinical through late-stage development.

Qualifications

• Bachelor's degree in STEM required.
• 8+ years of quality experience in GMP biotech manufacturing.
• 5+ years of effective management and leadership experience.
• Subject matter expertise in Quality Systems in a GMP biotech setting.
• Preferred ASQ certification is a plus.

Responsibilities

• Own the strategy, design and continuous improvement of the Quality Management System.
• Lead audit readiness and supplier/client/internal audits.
• Oversee Change Control, Deviations, CAPA and risk management activities.
• Define and report key quality metrics and escalation processes.
• Build and develop the Quality Systems team and leadership culture.
• Partner with cross-functional stakeholders to ensure compliance and right-first-time quality.

Skills

Quality Systems

GMP Biotech

Leadership

Veeva Vault

Education

Bachelor's degree in STEM

Job description

Landmark Bio seeks an Associate Director, Quality Systems to lead the strategy and continuous improvement of the Quality Management System supporting cell therapy, viral vector and fill-finish operations. Own core QMS functions including documentation, changes, deviations, CAPA, training and risk management.

The role drives audit readiness, supplier and client audits, and the overall Quality culture to support scalable, compliant operations from early clinical through late-stage development.