Associate Director, Quality Systems

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

The Associate Director, Quality Systems leads the strategy, design and continuous improvement of the Quality Management System supporting Artis BioSolutions' cell therapy, viral vector and fill-finish operations. The role owns core quality systems, including document management, change control, deviations, CAPA, training, supplier quality, and risk management. This individual will also lead audit readiness, and supplier and client audits. Throughout, it ensures these systems remain phase-appropriate, scalable and compliant with regulatory expectations.

The Associate Director builds and leads the Quality Systems team and partners closely with Technical Operations, Quality Control, Process Development and Data Technology Integrations. Through metrics, risk-based decision-making and a strong quality culture, the position enables the Quality department to support operations efficiently. In doing so, it advances Artis BioSolutions' mission of helping innovators bring life-changing therapies from bench to clinic.

Scope Of 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.
• Serve as the process owner for core quality systems including
• Documentation Management
• Training
• Deviations, CAPA, Effectiveness Checks
• Change Control
• Supplier Quality and Change Management
• Quality Risk Management
• Audit Management, including Supplier, Client and Internal
• Implement a quality risk management program consistent with ICH Q9(R1), and embed risk-based decision making across Quality and operational functions.
• Ensure compliance with applicable regulations and guidance documents
• Lead the company’s supplier, client and internal audit readiness program
• Support front-room or back-room audits, oversee timely and high-quality audit responses
• Own the internal audit program, including annual audit planning, execution, reporting and CAPA follow-up
• Oversee supplier qualification and monitoring program, including risk-based supplier audits and performance management
• Define, trend and report key quality metrics and indicators to identify systemic risks and improvement opportunities
• Lead the quality management review process and escalation significant compliance risks to senior leadership
• Build, lead and develop high-performing Quality Systems team, including recruiting, setting performance objectives, coaching and planning career development discussions
• Manage and own the Change Control Review Board
• Partner with internal cross-functional stakeholders to foster a strong Culture of Quality, promoting shared accountability for compliance and right-first-time performance
• Influence internal cross-functional stakeholders to drive timely closure of quality records

Education

• Minimum Bachelor's degree is STEM, such as biology, chemistry and engineering

Experience

• 8+ years of Quality experience working in a GMP biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy
• 5+ years of effective management and strong leadership experience

Knowledge & Skills

• Subject matter expertise in Quality Systems in a GMP biotech setting
• Preferred experience with Veeva Vault
• Relevant phase-appropriate GMP experience

Preferred Qualifications

• Preferred ASQ certification

Physical / Work Requirements

• Work environment: Office
• On-site expectations: 3 days on site per week
• Physical requirements: Standing, light lifting, ability to wear PPE when required
• Travel: None
• Schedule requirements: Monday - Friday, administrative hours
• Other requirements: N/A

Landmark Bio is an Equal Opportunity, Affiliation Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.