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

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

• Experience with network-based applications such as Oracle, Veeva

• In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; Biotech/Cell & Gene GMP regulations and applicability. (e.g. EU, FDA, ICH, USP, etc. or other industry best practices ex. ISPE, WHO, etc.)

• In depth knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.

• Critical Thinking and Problem Solving with ability to evaluate quality matters and make decisions utilizing risk based approach

• Ability to independently lead cross-functional teams, and effectively communicate with business stakeholders.

• Strong leadership skills with the ability to thrive in a high throughput environment

• Results driven and attention to detail to execute in a QA operational role.

• Ability to effectively communicate and influence others

• Excellent collaboration skills, and teamwork to partner within Quality and with stakeholders .