Associate Director, Quality Systems

Lever, Inc.; Massachusetts; Hybrid; USD 150,000 - 190,000; Full time

Job summary

Landmark Bio seeks an Associate Director, Quality Systems to lead strategy and continuous improvement of the Quality Management System across early clinical to late-stage development. You will own the quality manual, change control, deviations, CAPA, training, supplier quality and risk management, while enabling timely audit responses and a strong quality culture.

You will build and guide a high-performing team, partner with Operations, QC, Process Development and IT, and drive risk-based

Qualifications

• Bachelor’s degree in STEM (biology, chemistry or engineering).
• 8+ years in Quality within GMP biotech manufacturing (cell/gene therapy preferred).
• 5+ years of effective management and leadership experience.

Responsibilities

• Own strategy, design and continuous improvement of the Quality Management System across development phases.
• Establish and maintain quality manual, policies and procedure hierarchy.
• Lead audit readiness and supplier/client/internal audits, including CAPA follow-up.
• Define, trend and report key quality metrics to identify risks and improvements.
• Build and develop a high-performing Quality Systems team and oversee Change Control Board.
• Foster a Culture of Quality and ensure compliance with regulatory guidance.

Skills

Quality Systems

GMP Biotech

Leadership

Audit Readiness

Veeva Vault

Regulatory Compliance

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,andrisk management.This individual willalso leadauditreadiness,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 withTechnical Operations, Quality Control, Process Development andData 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 elevate 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

Required Experiences

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, Affimative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.