Associate Director, Quality Operations (Onsite)

Job Description

The site Quality Operations Associate Director oversees the operational execution at Cell & Gene Manufacturing site of the quality system processes such as documentation, training, and vendor in alignment with the global Vertex processes.    

The role will act as the liaison between various cross-functional partners within Vertex Cell and Genetic Therapies (VCGT) to coordinate compliant executing and within the global quality systems.   

This role is located at Vertex’s Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA-02210, 5 days on site (M_F).

Key Duties & Responsibilities 

• Contributes to the advancement and compliance of the site documentation and training programs by identifying opportunities and supporting risk-appropriate enhancements in line with the Global Quality systems.  

• Management of the documentation process including reconciliation of batch records, logbooks, and other GMP documentation.  

• Partner with internal manufacturing t Implement, develop and lead the monitoring of key quality system tiered metrics and risks to ensure the site operational execution is in a state of control. 

• Coordinates and oversees training activities together with the internal manufacturing coordinator within a GxP environment  

• Work with global quality and functional areas to ensure program is aligned to Vertex standards while also being scalable and flexible  

• Participate with stakeholder on operational vendor related issues impacting the site manufactured product.  Oversees risk based and phase appropriate resolution. 

• Monitors performance of vendors through operational feedback contributing operational input to the Global Vendor process as well as addressing SCARs, and other inputs.  Ensures escalation and compliant governance.  

• As a people manager within the organization, provides leadership, development and coaching to staff, in addition may have financial accountabilities and human resource responsibilities for assigned staff 

• Ownership of the Document Control Room at LC1 including cleanliness, organization, supply inventory, and room access. Gather stakeholder feedback to improve and gain efficiencies 

• Act as the operational site quality system SME for QS and strategic support to functional areas. 

• Clearly communicate program and status updates to managers, leadership, the Quality team, and stakeholders 

• Responsible for proper archiving of GMP documentation, including scanning and storage to Fan Pier 

Required Education Level 

• Bachelor's degree in an engineering/scientific discipline, or a related field