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.