Job Description The Vice President, Clinical Quality Assurance provides strategic leadership to the operational heads of CQA ensuring adherence to appropriate GLP, GCP, and data integrity requirements and industry standards, and proper management of compliance risk; works as a trusted business partner with cross functional leaders, to ensure alignment of strategic and operational goals and priorities such that Quality is integrated into our business plans, and the CQA team delivers results necessary to the attainment of our Company commitments to serving the patients that need transformational medicines; as a Company Quality Management Team member, plays a major role in defining the Company’s global Vision, Mission, Strategy; formulates innovative strategic direction and long-term vision for Company QA and the CQA function that optimizes assets and directly drives achievement of Company strategic objectives. The Head of CQA will design and empower the requisite organization structure and staffing to ensure the success of the CQA Unit. The VPCQA conducts his/herself in a fashion consistent with a trusted business partner and servant leader. He/she demonstrates Company Core Values, as well as Company QMT operating norms. Leading by example, he/she creates a culture that encourages candid, transparent sharing of information that drives continuous improvement, and fosters a positive work environment for all Company employees. He/she effectively communicates the social responsibility shared by the organization in leveraging excellence as a major contributor to providing patients with transformative medicines. Specific responsibilities include:   • Provides Strategic and regulatory compliance subject matter oversight and direction in deployment of the Company Quality Management System, resulting in substantial compliance with GCP/GLP and data integrity requirements     ◦ Collaborates with cross functional counterparts, defining and deploying the Company Quality Management System: ensures effective senior management QMS governance ; provides thoughtful, proper guidance and direction in the management of GCP/GLP risk; ensures sustained compliance resulting in positive inspection performance; and effectively communicates with executive management on matters of GCP/GLP compliance     ◦ Interacts with global regulatory agency representatives with technical, professional competence, achieving positive outcomes necessary for the success of the business     ◦ Maintains a vibrant professional network, staying current on leading edge regulatory agency and industry thinking.     ◦ Partners with and influences cross functional peers to ensure alignment/integration of the Quality vision and objectives with other business objectives to maximize the measureable business value of Quality   • Provides strategic leadership in the development of Line of Sight in the QA organization. Leads the translation of the QA Strategy into the vision, value proposition and strategic priorities for the CQA, and CQA operational plans/goals that are aligned with business partners and communicated in Quality and across the Company organization.   • Relentlessly explores leading edge, innovative principles and practices associated with progressive quality management; takes bold steps to incorporate into Company Quality strategy, Quality Management systems, practices; continuously drive meaningful change.   • Leads by example, directing the CQA team in planning operations via capacity based budget forecasting, resource management, project management/planning, and organizational management.   • Build and coach highly effective teams Minimum Qualifications Key Leadership Skills:   • CREATIVITY AND INNOVATION     ◦ Utilizes creative thinking processes and tools to arrive at simplified solutions for complex problems   • LIFELONG LEARNER     ◦ Demonstrates a high level of curiosity with a deep interest beyond their own vertical     ◦ Committed to continued self-improvement and team development   • RESULTS DRIVER:     ◦ Takes accountability and ownership and drives staff accountability through empowerment     ◦ Drives with urgency, expertise and judgment     ◦ Solid Project Management/ Time management skills   • PASSIONATE VISIONARY     ◦ Thinks strategically and articulates a clear and compelling strategy     ◦ Demonstrates solid knowledge and understanding of where Company is going   • TALENT DEVELOPER:     ◦ Teacher who shares what they’ve learned     ◦ Models resilience and adaptability in rapidly changing environment     ◦ Commitment to Team development/Team building   • CROSS-FUNCTIONAL COLLABORATOR     ◦ Ensures alignment by seeking out, assessing and incorporating feedback     ◦ Excellent Communication, Facilitation and Presentation skills     ◦ Ability to interact with customers and regulators; able to understand and translate customer needs Key Technical Knowledge, Skills and Competencies:   • Broad and deep global health regulatory agency knowledge and experience across multiple GxPs with particular expertise in GCP/GLP regulations and their execution/application across the drug product lifecycle   • Current knowledge of industry trends and best practices- for efficiency, compliance, effectiveness   • Extensive exposure with multiple regulatory agencies across GxPs/ multiple GxP representation during inspections   • Proven ability to design and /or implement Quality Systems   • Demonstrated strategic planning and execution skills required   • Successful record creating, building, designing, developing Quality organizations   • Developing individuals and teams; proven leadership capabilities within multi-level organization   • Creative, innovative leadership experience complemented with strong change management experience   • Demonstrated skill in Project Management, Capacity planning (budget and resource mgmt.)   • Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence   • Operational Excellence experience with proven ability to lead improvement projects-   • Strong problem solving and critical thinking skills   • Strong understanding of the core Clinical/Non Clinical business operations PREFERRED EDUCATION AND EXPERIENCE:   • M.S. (or equivalent degree) and 15 +years of relevant work experience, or B.S. in a scientific or allied health field (or equivalent degree) and 20+ years of relevant work experience, or relevant comparable background   • Professional association membership and participation preferred, not required (for example: RAPS; Lean Six Sigma training/certification; SQA (GCP/GLP); ASQ; DIA) Company Information Company is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Company has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases. Founded in 1989 in Cambridge, Mass., Company today has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For four years in a row, Science magazine has named Company one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit Company website. Company is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Company will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.