Waters Vice President, Global Quality & Regulatory Assurance in Milford, Massachusetts
The Vice President of Global Quality and Regulatory will provide leadership and partnership direction for US (Massachusetts, Taunton, New Castle, and Colorado), Europe (UK, Ireland & Romania), Asia and other global business sites; ensuring continuous improvement and high quality products access emerging regulated and clinical global markets worldwide. Leading a global organization of 150+ Quality and Regulatory professionals, the Vice President will create vision, strategy and tactics supporting exceptional product quality and customer experience throughout the product lifecycle within a matrixed Class I-II, IVD/IVDR, biotechnology instrumentation, and software product development environment.
Reporting to the SVP, Global Operations, this position will serve as enterprise leader for Quality & Regulatory performance and continuous improvement. This individual will act as an advisor, consultant, and subject matter expert to the executive team providing guidance and expertise in areas related to quality, compliance, regulations, and clinical documentation for global registration etc. He/she will be responsible for setting strategic direction for the company’s quality and regulatory policies and procedures.
By working closely with the company leaders and cross functional teams, this position will introduce and lead transformational efforts for improving product quality and driving and the culture of quality. This position is a key leader in the enterprise and will provide the overall leadership, continuous improvement, and direction both globally and to cross-disciplined stakeholders throughout the product lifecycle.
• Provide Clinical and Regulatory direction for strategic registrations in partnership with business leaders throughout the enterprise
• Responsible for Development, implementation, maintenance and overall success of the company’s quality and regulatory programs and strategy; including articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing process, establishing vendor relationships and quality standards and developing and implementing innovative programs to focus employees on improving product quality.
• Responsible for Regulatory Compliance and ISO certification for all Water products, operations and processes.
• Proactively partner with R&D, Marketing, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on the market globally
• Develop and implement regulatory and clinical policies and procedures aligned with the overall company strategy and targeted to meet desired risk as a business.
• Lead a team of the following disciplines; Design QA for Instrumentation, Software and Chemistry products, Engineering QA, Quality Management System, Quality Project Management, Quality Shared Services, Informatics Quality, Operations Quality, Regulatory and clinical professionals.
• Responsible for driving effective and efficient Quality Management System including driving harmonization and standardization, while ensuring QMS is established well with appropriate business processes in the company.
• Oversees the performance of internal and external audits.
• Responsible for Quality long-term strategy in coordination with leadership and in-line with overall company-wide strategy.
• Oversees the development of employees, talent, process, and technology necessary to reach annual and long-term objectives as organizational leader for Global Quality & Regulatory Assurance functions.
• Responsible for managing assigned budgets.
• Participate in due diligence and integration activities of domestic or foreign acquisitions
• Add line stating responsibility for EMR and other regular enterprise meetings
• Responsible PRRC. Person responsible for Regulatory Compliance
• Bachelor’s degree is required in a science or engineering area.
• Advanced degree is a plus (PhD, M.S. in a Life Science or MBA) as well as any professional certifications (i.e. RAC, Six Sigma, ASQ certifications).
• Minimum of 15 years of experience leading combined Quality Assurance/Quality Engineering and Clinical Regulatory organizations within the medical device, biotechnology, or similar life sciences arena.
• Experience with Class I and II medical devices/systems and in vitro diagnostics experience highly desirable. Class III medical device experience is a plus.
• Prior experience in a senior leadership role setting strategic direction for the company's quality & regulatory policies and procedures is required.
• Strong understanding and ability to critically review Quality Systems, Engineering and Compliance.
• Strong understanding of quality requirements successfully implementing cGMP/QSR, ISO 9001/13485, FDA, six sigma and lean manufacturing programs.
• Strong understanding of global registration requirements and demonstrated track record of successful market access.
• Strong track record of change management and success working cross-functionally.
• Proven ability to build a strong team of direct reports and to actively develop the team’s potential through coaching and effective performance management.
• Exceptional team building skills and demonstrated ability to direct activities from concept through to completion.
• Proven ability to create culture of accountability and ownership.
• Multi-dimensional thinker who operates not only based on past experiences but considers new approaches and developments.
• Strong team orientation and team builder.
• Ability to mentor and development members of the Quality team.
• Able to travel domestically and internationally.
Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years. With more than 7,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.
Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. We strive to be better, learn and improve every day in everything we do. We’re the problem solvers and innovators that aren’t afraid to take risks to transform the world of human health and well-being. We’re all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow.
Diversity and inclusion are fundamental to our core values at Waters Corporation. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization. We are united by diversity and thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.
Executive, Leadership, Quality Assurance, Regulatory Assurance, Clinical, Medical Devices, ISO9001, ISO14971, ISO13485, IVDR, Vice President
Company Name: Waters Division
External Company URL: www.waters.com
Street: 34 Maple Street