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

Position Summary

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.

Key Duties & Responsibilities

The responsibilities of this position may include, but are not limited to, the following:

• 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.

Required Education Level

• Bachelor's degree in a scientific discipline, operations research, operations management, business administration or a related field

Required Experience

• Requires 10+ years of experience or the equivalent combination of education and experience
• Experience in product life cycle from discovery to commercial product development

Required Knowledge/Skills

• Broad and deep expertise in global GMP regulations, guidances, and Quality Management Systems, as well as a strong understanding of industry standards and best practices across the GxP life cycle
• Strong leadership skills with ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment
• Ability to assess impact across multiple procedures and systems
• Ability to lead and manage complex projects/teams within corporate objectives and project timelines
• Proficiency utilizing project management processes / tools to lead meetings, assist with project planning and facilitate completion of tasks
• Excellent technical writing, presentation and communication skills
• Ability to effectively influence others within technical area of expertise
• Outstanding facilitation, communication, and coaching/influencing skills
• Proven ability to lead improvement projects and project teams
• Ability to navigate through ambiguity and rapid growth and adapt to change
• Proven ability to identify and analyze performance indicators.
• Extensive experience conducting investigations, performing root cause analysis and identifying CAPA

Other Requirements

Up to 15% travel