Senior Director, Quality Control

Job Description

General Summary:

This critical senior position is responsible for leading the Commercial Quality Control team within the Commercial Manufacturing and Supply Chain Division. The incumbent will be responsible for leading a diverse team that is responsible for executing release and stability testing of all commercial programs across multiple modalities including small molecules, Cell and Genetic Therapies and Biologics. As well as leading established teams and platforms, the leader will be responsible for building new capabilities required for emerging pipeline assets and supporting routine manufacturing operations to ensure timely and quality products are delivered to patients.

The team will be responsible for building a scalable QC network, heavily leveraging external testing capabilities and Contract manufacturing and testing organizations to test products and raw materials. The team will lead the development and implementation of robust, complaint and efficient business processes to enable manufacturing and product disposition. The head of this group will also cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges.  

Key Duties and Responsibilities:

• Responsible for building a comprehensive external network of commercial QC testing capabilities that are in line with the business needs to support reliable supply of high-quality medicines to patients. The team will support diligence exercises to identify new testing sites and be responsible for bringing new testing sites into the QC network for all commercial programs. The team will be responsible for building logistics and scheduling capabilities to ensure that all samples are shipped and tested to support business needs in a timely and reliable manner. This may also include establishing internal laboratory capabilities to support routine testing and investigations.  

• Build a high performing team by recruiting and developing strong talent, ensuring the development and implementation of training required to fully qualify staff for establishing and maintaining capable and controlled processes. Lead and develop a strong winning culture, fostering teamwork and commitment to excellence through transparent communication and staff engagement. Ensure the correct capabilities, resources and teams are built and in place to meet the needs of the business.  

• This individual will be responsible for building and maintaining relationships with external contract testing labs used for commercial QC testing of drug substance/drug product batches, critical components and raw materials. This includes negotiating business terms with suppliers to ensure that Vertex’s goals are met, and interests are maintained to the highest standards. The individual will design and lead a fit-for-purpose governance structure with the suppliers to appropriately monitor performance and build long-term strategic capabilities and capacity to meet the needs of the business.  

• This individual will work closely with the supply chain team to continually assess manufacturing capacity to ensure sufficient analytical capacity is established at the contract testing labs to support the testing needs of each commercial program.  

• The team wi