Summary of Major Responsibilities
The Vice President, Quality will define Exact Sciences’ global Quality strategy with respect to its organization, quality management system, and quality processes. This role will drive implementation of the Quality organization’s focus and controls across the US Cologuard business, product pipeline, and company acquisitions. This role will lead the strategy with key stakeholders from a variety of functions including Operations, Regulatory, R&D, Lab Operations, and Commercial to support manufacturing, product development, post-market surveillance, and commercial activities. The Vice President, Quality, ensures compliance to 21CFR820, ISO13485, 42 CRF 493 (CLIA), New York State Department of Health, California, and other applicable regulations in accordance with applicable state, federal and international laws, and carries out compliance activities.
Essential Duties and Responsibilities
- Leads all aspects of the Quality organization including building quality functional capabilities, building the team globally and across business units and driving the functional strategic talent review process.
- Develops the quality strategy, drive its implementation, put in place the processes and procedures, and create the organization needed to meet and exceed the Exact Sciences corporate priorities.
- Leads the quality function to assure operational excellence in and compliance to standards, quality policies and processes.
- Develops and maintains the Quality metrics dashboard and manage report out of quality scorecards.
- Facilitates benchmarking process to identify key enablers to improve our profitability, customer satisfaction, employee engagement and retention.
- Leads the quality organization and business in utilizing quality tools to drive root cause analysis using robust problem-solving techniques to facilitate world class quality performance.
- Develops and maintains best business practices and other benchmark principles. Drive these tools usage into all levels of the organization.
- Champions change management processes.
- Manages the company quality system and acts as a liaison to all areas of the business.
- Reports to Executive Management on the status of the quality system as well as any noncompliance issues that surface; and ensures that corrective action is appropriately implemented.
- Provides Executive Management with timely communication of new regulatory agencies and new directions and publications.
- Escalates to Executive Management any quality concern on a timely manner.
- Builds a robust team to support and meet company objectives.
- Communicates schedule, timelines, and priorities as well as the team’s strategic direction.
- Establishes objectives for team and manages to ensure that work products meet quality standards. Monitors the completion of tasks within timeframe and cost constraints and ensures that functional needs are met.
- Expert on trends and regulations to ensure effectiveness and compliance.
- Develops and monitors budget for labor and capital expenditures.
- Current knowledge and understanding of all relevant US and International Regulations.
- Demonstrated ability to lead people and get results through others.
- Ability to interface, collaborate and work effectively with all levels in the company, customers, etc.
- Ability to think ahead and plan over a 12-24 month timeframe.
- Excellent communication and listening skills, both verbal and written.
- Must be proficient in using basic software applications including Microsoft Office (Word - generate documents and tables, Excel - able to create and modify spreadsheets, create complex formulas, etc.).
- Proven exceptional organizational skills.
- Ability to work in a team environment and adapt to changing plans and circumstances.
- Ability to handle multiple projects and priorities simultaneously in a fast-paced environment.
- Strong problem solving and decision-making skills.
- Strong attention to detail.
Education and Experience
- Bachelor’s degree in life sciences or equivalent field; or the equivalent combination of education and experience.
- 15 years of experience in Quality Leadership.
- 15 years of Quality experience, 5 out of the 10 years should be working in an in vitro diagnostics business and CLIA lab environments.
- Experience in a Biotech manufacturing environment with cGMP FDA regulated and ISO 13485 environment.
- Experience preparing for and hosting audit by Regulatory Authorities.
- Master's degree or Ph.D. in life sciences field.
- Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.
- Ability to frequently and accurately communicate with customers and management face-to-face, via the telephone or by email.
- Ability to travel (by land and/or air), both domestically and internationally.