Senior Director Quality CGT Personalized Medicine
Overview
Strategic Quality leadership for personalized medicine and advanced cell therapies across the patient journey. Accountable for advancing Quality oversight governance compliance and continuous improvement while ensuring efficient patient-centric processes. Cross-functional matrix leadership partnering with Global Quality Manufacturing Regulatory Commercial and Supply Chain stakeholders. Influence enterprise decisions build partnerships and drive alignment through executive presence and effective communication.
What You'll Do16
- 1Lead strategic Quality Systems leadership supporting personalized medicine advanced CGT programs aligning with CGT Business Objectives Vertex Global Quality Strategy commercial priorities regulatory expectations and patient-centered outcomes
- 2Define prioritize and execute CGT Quality Systems across clinical launch and commercial lifecycle stages
- 3Partner with stakeholders to ensure effective risk management resolution and mitigation plans
- 4Lead mentor and develop team members building organizational capability fostering accountability collaboration innovation and operational excellence
- 5Leverage technical and Quality expertise across CGT QA to resolve critical challenges drive timely decision-making and ensure effective communication escalation of risks constraints and commitments
- 6Create and foster a culture of collaboration quality excellence continuous improvement transparency and accountability across Quality and partner functions
- 7Responsible for leading and participating in key CMC Quality initiatives to advance and mature Vertex’s Global Quality Systems
- 8Provide End to End compliance oversight for personalized medicine advanced CGT internal and external quality operations ensuring compliance with enterprise Vertex Global Quality procedural requirements and global regulations
- 9Establish compliance governance routines to proactively monitor compliance trends operational performance and emerging risks that may impact product quality patient safety supply continuity or program execution
- 10Lead or support risk-based mitigation plans continuous improvement actions and sustainable process enhancements
- 11Partner with digital stakeholders to embed CGT user requirements in lifecycle management projects from design through implementation including sustainment
- 12Support inspection readiness and audit-related activities related to Quality CGT oversight
- 13Chair or support cross-functional review of GMP related patient treatment journey requests involving patient-specific constraints
- 14Ensure Quality Management Review Boards are executed in line with Global Quality System requirements when quality or compliance impact is identified across the patient treatment journey
- 15Partner with Global Quality and cross-functional stakeholders to support development and deployment of advanced digital reporting solutions and use of artificial intelligence in CGT to enable transparent governance decision-making and escalation of quality and operational risks
- 16Improve compliance and strengthen proactive quality management efficiency data integrity and processes maturity and scalability across CGT investigations change controls risk assessments CAPA and management review
Requirements11
- 1Bachelor’s degree in engineering life sciences pharmaceutical sciences or related technical discipline required
- 2Master’s degree in business analytics management life sciences or related field preferred
- 315+ years of experience and 7+ years in a management supervisory role or equivalent combination of education and experience in a regulated pharmaceutical environment
- 4Broad experience in quality and compliance oversight for allogeneic autologous cell manufacturing processes or other personalized medicine modalities from development through commercial lifecycle
- 5In-depth knowledge of global health authority expectations and GxP requirements across the lifecycle for cell and gene therapy biologics and advanced therapy products
- 6Enterprise Impact and Influence ability to shape decisions across the organization through strong partnerships communication and executive presence
- 7Ability to apply risk management principles critical thinking and problem solving skills
- 815% travel hybrid role in Boston MA
- 9Pay Range $180800 - $271200
- 10Eligibility for annual bonus and annual equity awards
- 11Flex eligibility hybrid or on-site
Salary Insight
$181 - $271k per year
Location
Required Skills
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