Associate Director, Quality Systems

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

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.