Senior Director, GMP Operational Quality - Cell & Gene (Onsite)

Job Description

The Senior Director, GMP Operational Quality Assurance will be responsible for the oversight of Site Quality Operations for the Manufacturing of Cell & Gene products.  The role will be responsible for leading the Quality on site operations team across multiple shifts for internal clinical and commercial manufacturing operations. Responsibilities include day-to-day operational quality oversight for internal batch record review, batch disposition and manufacturing operations across the end-to-end manufacturing processes for the manufacture of clinical and commercial intermediates and drug product batches. 

Responsibility includes ensuring all shift quality operational activities are completed in time by identifying technical risks and mitigations, participation in governance committees and improvements to the disposition process.    

This is an onsite role, 5 days in a week at the Leiden Center, Vertex Pharmaceuticals, Seaport, Boston.  

Key Duties and Responsibilities:

• Directs multiple teams responsible for internal commercial and clinical operations in support of GMP manufacturing and testing activities, including disposition of intermediates, clinical and commercial cell therapy products internally at Vertex manufacturing facility.   

•  ​Responsible for clinical and commercial batch release, for US, Canada, UK, EU and ROW markets including liaising with QP certification and importation requirements where applicable.  

•  Monitors operational activities and assesses continuous improvement within the QA operations.    

• Proactively identify trends/gaps/risks and implement plans to mitigate such trends/gaps and risks.  

•  Leads Material Review Board (MRB) discussions, as necessary in case any quality event  

• Ensures quality staff assesses and approves change controls for commercial processes for assessment of lot disposition processes.    

• Leads and manages highly complex projects/teams within corporate objectives and project timelines  

• Provide support/lead or assist with preparing for and hosting partner audits and regulatory agency inspections.  

• Responsible for team development Lead, develop, and implement Quality strategy and compliance principles throughout product lifecycle management within the Cell & Genetic Therapies product portfolio

Knowledge and Skills:

• In depth experience in all stages of clinical product development to commercialization product life cycle management.  

• Direct experience with regulators (e.g., BLA, MAA submissions and/or inspections).  

• Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.  

• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.  

• Ability to apply critical thinking and problem solving skills to decision making and operational priorities.  

• Strong leadership and an innate ability to mentor, collaborate and build relationships