Vice President, Global Quality & Regulatory Assurance
Company: Regional Recreation Corporation of Wood Buffalo
Posted on: May 2, 2021
Vice President, Global Quality & Regulatory Assurance in
Milford, Massachusetts - Careers at MA - Milford Skip Branding Vice
President, Global Quality & Regulatory Assurance in Milford,
Massachusetts - Careers at MA - Milford Skip to Main Content Please
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Candidate? Log back in! Vice President, Global Quality & Regulatory
Assurance Req. # 13481 Company Name Waters Division Category
Quality Assurance Location US-MA-Milford Type Regular Full-Time
Overview 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. Responsibilities --
Provide Clinical and Regulatory direction for strategic
registrations in partnership with business leaders throughout the
-- 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
-- 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
-- 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 Qualifications -- 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,
-- 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
-- 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
-- Strong understanding of global registration requirements and
demonstrated track record of successful market access.
-- Strong track record of change management and success working
-- 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
-- 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
-- Able to travel domestically and internationally. Company
Description 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.-- Key Words Executive, Leadership, Quality Assurance,
Regulatory Assurance, Clinical, Medical Devices, ISO9001, ISO14971,
ISO13485, IVDR, Vice President Options Apply for this job online
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Keywords: Regional Recreation Corporation of Wood Buffalo, Milford , Vice President, Global Quality & Regulatory Assurance, Executive , Milford, Connecticut
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