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will provide QA oversight of the quality control bioassay and flow cytometry laboratories along with raw material, analytical development, and supply chain groups in support of Vertex Clinical Cell and Gene Therapy Programs. Emphasis on review and approval of quality event management (deviations and analytical investigations (OOS/OOE)), QC and AD owned protocols and reports supporting analytical method lifecycle, justification of material specifications, and stability studies. The role will have additional responsibilities for QA review of documentation supporting change controls, including but not limited to analytical and process development reports and studies.

This position reports to Director Product Quality Lead / GMP Quality - Cell & Gene.

Key Knowledge/ Skills and Competencies

• Knowledge in the following areas:

• Experience with GxP requirements governing review of Quality Control data, analytical method qualification, and laboratory control requirements.

• Direct experience executing, troubleshooting, or investigating flow cytometry, ELISA, bioassay, and automated cell counting QC methods.

• Experience supporting GMP testing in a controlled environment (QC and AD), deviation review and oversight, corrective action / preventative action (CAPA), change management, and coordinating risk assessments .

• Ability to thrive in a fast-paced environment

• Collaboration / Teamwork

• Proven track record working on cross-functional teams

• Communication

• Ability to communicate effectively across and within cross-functional teams

• Critical Thinking / Problem Solving

• Ability to evaluate quality matters and make decisions utilizing risk-based approaches

• Attention to detail

KEY RESPONSIBILITIES:

• Providing quality oversight and support to Vertex Cell and Gene Therapy quality control, stability, supply chain, and raw material laboratories

• Review AD and QC raw data, including data verification, of method lifecycle and stability reports

• Review of deviations and other quality systems records (CAPA and Change Controls) as applicable to support AD/QC lifecycle initiatives

• Responsible for identifying risks and communicating gaps for GMP process/systems associated with analytical, stability, and raw material laboratories

REQUIRED EDUCATION AND EXPERIENCE:

• Bachelor’s degree in a scientific or allied health field with minimum 5+ years of relevant work experience, 3+ years experience in QA role preferred.

• Experience providing QA support and oversight of GMP QC testing operations including batch release and CoA generation

• Experience with clinical phase ATMP and Cell Therapy drug product manufacturing and QC testing

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

LEADERSHIP COMPETENCIES:

• Be adaptable and resilient when confronted with change

• Provide constructive feedback to peers to help bring out their best; seek out and respond favorably to feedback provided

• Actively work to resolve conflict in a productive manner, focused on shared goals

• Find new, creative paths to solve difficult and important problems

• Demonstrate understanding of how your work fits into and supports the work of other groups or functions