Associate Director, Quality Systems

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

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