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 escalate 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
Minimum Bachelor’s degree is STEM, such as biology, chemistry and engineering
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
Subject matter expertise in Quality Systems in a GMP biotech setting
Preferred experience with Veeva Vault
Relevant phase-appropriate GMP experience
Preferred ASQ certification
Education
Experience
Knowledge & Skills
Preferred Qualifications
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
To Apply
Please submit your resume/CV along with a brief cover letter describing your relevant experience for one or more applicable areas indicated above.
Skills Required
- Bachelor's degree in a STEM field such as biology, chemistry, or engineering
- 8+ years of Quality experience in a GMP biotechnology manufacturing environment
- Hands-on experience with cell and/or gene therapy is preferred
- 5+ years of effective management and strong leadership experience
- Subject matter expertise in Quality Systems within a GMP biotechnology setting
- Relevant phase-appropriate GMP experience
- Experience with Veeva Vault
- ASQ certification
What We Do
Landmark Bio is a collective endeavor launched by leaders from academia, the life sciences industry, and world-renowned research hospitals to accelerate development and industrialization of next-generation genomic medicine. Inspired by recent advancements in cell and gene therapy, Landmark Bio was established to remove barriers in drug development, create accessible capability, expertise, and solutions, and offer a collaboration platform to advance manufacturing technologies for the new generation of medicines to come. Founding partners include Harvard University, Massachusetts Institute of Technology (MIT), Cytiva, FUJIFILM Diosynth Biotechnologies (FDB), and Alexandria Real Estate Equities, Inc. Other collaborating institutions include Beth Israel Deaconess Medical Center, Boston Children’s Hospital, Mass General Brigham, and the Dana-Farber Cancer Institute. For more information please contact [email protected]
Why Work With Us
Landmark Bio was conceived to accelerate life sciences innovation. Our cross-sector network, expert staff and consultants, state-of-the-art facility, and broad definition of how a true partner can expedite translational research make us unique. Our mission Is to translate groundbreaking research into life-changing therapies.
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