Waters Senior Director, Global Quality Services in Milford, Massachusetts

For over 50 years, Waters Corporation has developed innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance. Specifically, the company designs, manufactures, sells, and services high performance liquid chromatography, ultra performance liquid chromatography, and mass spectrometry technology systems and support products primarily in the United States, Europe, Japan, and Asia. Our innovations enable significant advancements within the pharmaceutical, life science, biochemical, industrial, food safety, environmental, academic and government industries. Waters is a publicly traded corporation (NYSE:WAT) with more than 6,500 employees and is represented in over 100 countries around the world.

Waters Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.

Waters Corporation is currently leading a search for a Senior Director of Global Quality Services to join our outstanding organization. In this role, the individual will lead the Global Quality Service activities and associated responsibilities across all global sites within Waters and associated businesses. The sites include, but not limited to, Waters US, Europe and Singapore in support of Waters product portfolio including the Mass Spectrometry and Chromatography instruments, our Class I/II instrumentation and systems, in-vitro diagnostics (IVD) offerings, chemistry/consumables, and scientific software. This role will also support other business segments within Waters such as biomaterials, pharmaceutical, food, medical device, environmental, clinical, and academics/government research.

This Sr. Director will lead our Global Quality Services organization in providing key functional and business applicable services which will result in higher performance of Quality function processes and systems as well as applicable business systems and processes. This role will be key in ensuring excellence in systems harmonization and standardization, driving key programs management for both Quality function and participating in key business projects, supporting to achieve highest product and process quality, enabling technology solutions (IT/BT tools), driving continuous improvement activities, and supporting the local quality and other leaders to achieve desired outcomes.

This Sr. Director will also develop an understanding of the company’s current products and procedures and implement new/enhanced quality practices and services throughout the company. This individual will work with all business partners and functions including Global Services, Business Technology, R&D, Manufacturing and other key functions, and champion Quality Services efforts at both local business sites and at global levels. This individual will establish and develop strong working relationships with all our internal and international organizations, as appropriate, and work with cross-functional teams to accomplish common goals. This individual will maintain strong, productive working relationships with customers, industry experts, and regulatory agencies as appropriate. This individual will also develop relationships as appropriate with the other R&D and Manufacturing organizations outside of the United States.

This Sr. Director will assist in the development of Global Quality strategy, and lead the implementation and execution of the strategy where applicable. This individual will operate at a senior level to drive Quality efforts that will result in higher efficiencies and effectiveness in all we do, including meeting all company and statutory regulatory requirements.

  • Provides solutions and options for Quality and Business processes and systems while supporting local Quality needs and other business interests

  • Participates in the development and implementation of Global Quality strategy and accomplishes the key performance objectives as applicable to Global Quality Services.

  • Leads Global Quality Services organization to drive, but not limited to,

    • Harmonization and standardization efforts across all sites
  • Training systems and processes across all applicable sites

  • Key programs to drive continuous improvements for Quality function and participates in critical business projects

  • Establishes global policies and guidelines

  • Leads key Quality function programs and manages them to completion while supporting local Quality teams

  • Participates in the business projects to represent the interests of Global Quality and site Quality requirements

  • Works closely with Business Technologies to develop Quality Management System – BT strategy ad roadmap, and implementation

  • Provides inputs, guidance and expertise as appropriate in identifying enabling technology solutions that meets both Quality and business needs and interests

  • Leads all Quality Services functional responsibilities across all sites

  • Leads the development and management of key metrics and balanced scorecard that can be used at all sites as well as applicable metrics for Global Quality representation

  • Works closely with Global Services, R&D, Manufacturing and other functions to represent Global Quality Service interests

  • Works with all sites and ensures the solutions, processes, systems and implementations meet both the site and company-wide interests and requirements

  • Ensures the enabling tools, technologies meet Quality requirements while supporting both business systems, tools and BT/IT requirements

  • Works with Informatics team and other software and computer systems functions and processes to ensure all requirements are met to quality standards

  • Works with Global Quality leaders of all sites to identify and implement a standardized Executive Management Review process and summaries

  • Works closely with appropriate functions to provide computer systems validation (CSV) and recommendations

  • Works to develop annual budgets and manages the budget to ensure appropriate spend to meet financial requirements

  • Manages employees to ensure highest performance and supports them in their development and career growth while providing feedback and driving accountability

  • Works with all Quality leaders at all sites to identify opportunities to drive efficiency and effectiveness of process improvements

  • Supports any business development opportunities to represent Quality interests

  • Perform other duties as assigned

  • Minimum of a Bachelors Degree required.

  • Advanced degree is preferred (PhD, M.S. in a Life Science, MBA or equivalent)

  • Professional certification is strongly desired (i.e. Six Sigma, ASQ certifications, PMP).

  • Minimum of 10 years of experience leading Quality function within the medical device/Biotechnology, Life Sciences or similar discipline arena.

  • Minimum of 7 years in managing employees

  • IT experience is highly desired and familiarity of tools used in Quality Management System

  • Experience with Class I/II/III medical devices/systems and/or in-vitro diagnostics (IVD) experience is highly desired.

  • Prior experience in a senior leadership role with overall responsibility for directing a Quality organization is required.

  • Able to work effectively globally.

  • S/he must have a strong understanding of quality requirements.

  • Good understanding of product development process, new product introduction (NPI), preproduction and supply chain quality control is a plus.

  • S/he will have the ability to identify and analyze complex problems and recommend actions.

  • This position will develop schedules, budgets and have a comprehensive understanding of business objectives.

  • Able to effectively manage teams and projects/programs.

  • S/he will have proven track record in a matrix environment, exceptional team building skills and demonstrated ability to direct activities from concept through to completion.

  • Outstanding Work Ethic.

  • Effective communication and influencing skills.

  • High energy problem solver/achiever – Self Starter

  • Well-Organized and Detail-Oriented

    • Strong team orientation and team builder
  • Ability to mentor and development members of the team

  • Successful History of Achievement

  • Experienced International Business traveler

  • Business financial analytics experience

Company Name: Waters Division

External Company URL: www.waters.com