Knowledge and Skills: • Good understanding of both the conceptual and practical application of cGMPs in a pharmaceutical setting • Proven experience leading a variety of straightforward projects/teams within stated objectives and timelines • Ability to communicate effectively with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint • Ability to manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes • Formal project management experience • Strong communication skills (written and verbal) with the ability to communicate to a variety of audiences • Ability to integrate activities with other groups, departments and project teams as needed • Demonstrated ability to evaluate quality matters and solve problems leveraging technical experience and advanced judgement to select appropriate solutions • Excellent team player and collaborator • Highly proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA • Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva). Key Duties and Responsibilities: • Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions • Lead root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified • Perform change control assessments and closure approvals • Establish and revise Quality Agreements between CMOs/Suppliers and Vertex, as needed • Collect data and report on metrics • Represent Vertex Quality on cross functional working teams, applying strong communication and collaboration skills • Lead continuous improvement projects • Author SOPs to support commercial quality functions • Assist with regulatory agency inspections • Identify and facilitate continuous improvement efforts • Train employees and provide insights and education on processes and procedures • Perform activities associated with product disposition (e.g., batch document review, source data review etc.) • Gown into cleanrooms and controlled environments.