Associate Director, Quality Systems

Artis BioSolutions

Watertown, MA, United States2w ago

Free account needed to apply or save. It takes a minute, and we'll bring you right back to this job.

Key details

Location
Watertown, MA, United States
Work style
Hybrid
Level
Lead / Staff+
Job type
Full-time
Experience
8–11 yrs
Function
Legal & Compliance
Focus area
other
Posted
2w ago

Skills

capachange controldocument managementgmpinternal auditperformance managementquality auditsquality controlquality managementquality management systemsvault

About the role

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

Get jobs like this as soon as they're posted

ApplyHour checks company career sites all day and ranks every opening against your profile. Free to join.

Create a free account