Senior Manager, GMP Operational Quality, Cell Therapy (Second Shift)

Job Description

The Senior Manager will lead the day-to-day QA oversight including execution of batch disposition at the Vertex CPI and Drug Product Facility in support of manufacturing operations.  The Quality Assurance Senior Operational Manager is recognized as an expert internally in the principles and application of quality assurance and compliance at the Cell & Genetic manufacturing site.  

Other key areas include QA oversight of analytical laboratory operations, environmental labs, and materials management.  This role will drive, review & support activities related to product disposition including review of batch data, batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation across all phases of development and commercial. 

This role is located at Vertex’s Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA-02210. This is a second shift role from Sunday to Wednesday 12:30 to 11pm.

Key Duties & Responsibilities 

• Responsible for leading quality oversight of shift manufacturing operations including analytical laboratory, materials management and manufacturing operations. 

• Responsible for GMP batch disposition activities including review and approval of batch records, deviations, in-process data, EM data, QC release testing, materials review board and other quality activities as applicable to determine acceptability of product disposition. 

• Provide QA support of change controls, process and OOS investigations, and associated CAPAs.  

• Responsible for approval of Manufacturing & QA documents e.g. MBR, APSs, COAs and product labelling. 

• Support technical transfer, review and approval of manufacturing documents and process performance qualification activities. 

• Responsible for proactive identification of compliance risks and gaps for GMP processes including execution and implementation of mitigating controls 

• Support audit and inspection readiness activities. 

• Act as a trusted advisor by providing compliance guidance through collaborative review and partnering with business stakeholders and contract manufacturers. 

• Maintain, track and report performance and batch record metrics. 

• Execute improvements to QA operations processes. 

• Participate/ lead Cell & Genetic Program and Quality projects and drive continuous improvement activities. 

Required Education Level 

• Bachelor's degree in a biotech/ Life sciences field. 

• Preferred Master's degree or relevant comparable background. 

Required Experience 

• 6+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.  

Required Knowledge/Skills 

• Demonstrated experience providing/leading QA support to GMP manufacturing operation on the manufacturing floor and as a QA reviewer working with Batch Records or in QC Analytical role.   

• Experience successfully leading event investigations, Root Cause Analysis and CAPA