Quality Systems
Posted 25 Sep 2026
Advertised as “Associate Director, Quality Systems”
BranchFactor Summary
The original posting with the fluff stripped out
- Expected experience
- 8+ yrs
- Management level
- People management
- Employment
- Hybrid
- Contract
- Full-time
No salary listed for this role.
Field of studyScience, Technology, Engineering, and Mathematics
Study levelBachelor's
CertificationsASQ Certification
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
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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.
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Establish and maintain the quality manual, quality policies and the governing procedure hierarchy.
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Serve as the process owner for core quality systems including
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Documentation Management
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Training
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Deviations, CAPA, Effectiveness Checks
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Change Control
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Supplier Quality and Change Management
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Quality Risk Management
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Audit Management, including Supplier, Client and Internal
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Implement a quality risk management program consistent with ICH Q9(R1), and embed risk-based decision making across Quality and operational functions.
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Ensure compliance with applicable regulations and guidance documents
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Lead the company’s supplier, client and internal audit readiness program
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Support front-room or back-room audits, oversee timely and high-quality audit responses
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Own the internal audit program, including annual audit planning, execution, reporting and CAPA follow-up
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Oversee supplier qualification and monitoring program, including risk-based supplier audits and performance management