Quality Systems Strategy Lead

Landmark Bio, LLC; Watertown (MA); On-site; USD 180,000 - 230,000; Full time

Job summary

Landmark Bio in Watertown, MA, seeks an Associate Director, Quality Systems to lead strategy and continuous improvement of the Quality Management System for cell therapy and biotech operations. You will own core systems, drive risk-based decisions, and ensure regulations are met across audits and CAPA.

You will build and coach a high-performing team, partner with Technical Operations and Quality Control, and embed a strong culture of quality across the organization, enabling scalable, compliant

Qualifications

• 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.

Responsibilities

• Own the strategy, design and continuous improvement of the Quality Management System, ensuring it is phase-appropriate, scalable and aligned with company growth from early clinical through late-stage development.
• Establish and maintain the quality manual, quality policies and the governing procedure hierarchy.
• Lead audit readiness, and supplier and client audits, including internal audits.
• Define, trend and report key quality metrics and indicators to identify systemic risks and improvement opportunities.
• Build, lead and develop a high-performing Quality Systems team, including recruiting and coaching.
• Partner with cross-functional stakeholders to foster a Culture of Quality and drive timely closure of quality records.

Skills

Quality Systems

Leadership

GMP Biotech

Cross-functional collaboration

Education

Bachelor's degree in STEM

Tools

Veeva Vault

Job description

Landmark Bio in Watertown, MA, seeks an Associate Director, Quality Systems to lead strategy and continuous improvement of the Quality Management System for cell therapy and biotech operations. You will own core systems, drive risk-based decisions, and ensure regulations are met across audits and CAPA.

You will build and coach a high-performing team, partner with Technical Operations and Quality Control, and embed a strong culture of quality across the organization, enabling scalable, compliant