Associate Director, Quality Systems - Cell and Gene Therapies (VCGT)

The Quality Systems Associate Director supports strategic design of and ensures tactical execution of quality systems, risk management, and quality culture across the Vertex Cell and Gene Therapy (VCGT) organization. The role is responsible for partnering with cross-functional technical development and commercial teams to align and facilitate harmonization of strategy, procedures and processes related to the Quality Management System and to drive Quality improvements. 

This position reports directly to the Director of Quality. 

-Process Lead for Annual Product Quality Review (APQR) and Quarterly Product Quality Assessment (QPQA) including: 

• Responsible for leading and providing functional process oversight for APQR and QPQA 

• Ensure all APQR and QPQA are executed on time and in accordance with procedures and regulatory requirements 

• Monitor and support the quality risk management program items associated with CGT.  Identify and implement continuous improvement projects to improve processes and make them efficient and scalable 

-Process Lead for VCGT Data Integrity (DI) program 

• Define DI compliance operational strategies to be deployed at the local site level and monitored for effectiveness, including governance 

• Collaborate with Global Process owner to identify and implement DI continuous improvement projects to mature processes and make them efficient and scalable 

• Responsible for local Quality system oversight, metrics, and improvement including change control, events, CAPA, escalation, and risk management 

• Leads the monitoring, interpretation, and communication of QMS processes and metrics requirements including remediation plans 

• Collaborates with internal and external business partners to resolve complex quality issues to ensure compliant solutions 

• Provide hands-on expertise in the day-to-day management of data collection systems and control within the GxP Quality Management System using digital solutions 

• Responsible for strategic, Risk Management monitoring support, and Data Integrity initiatives and activities to drive prioritization and in-support continuous improvement across VCGT QMS/Compliance processes  

• Supports internal audit or external audit programs 

• Works to enhance Quality Culture across VCGT organization 

• Provides Project Management leadership for department projects/initiatives. 

• Requires 10+ years of experience or the equivalent combination of education and experience <