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US - New Jersey - Fair Lawn
Job Description

Director, Global Quality and Regulatory Affairs

We’re looking for an experienced transformational leader for our Laboratory Chemicals Division (LCD). This impactful role will develop short and long-term strategies to drive results in our Quality and Regulatory Affairs function.

How will you make an impact?
This is a critical role on our leadership team which collaborates with a variety of stakeholders across our matrixed organization.

As a Quality Leader you’ll be responsible for building a customer-focused quality culture. This includes a commitment to optimizing the customer experience through customer feedback and delivering products that represent industry-leading standards of product quality.

What will you do?

  • Oversee the development and deployment of Quality Management Systems (QMS) at several locations, acting to ensure site-to-site harmonization of documented systems that comply with the requirements of all regulatory standards and agency authorities to which Laboratory Chemicals is accountable – including ISO, and corresponding authorities of other nations.
  • Lead and inspire the Quality Function by establishing an organizational structures and Quality policies that are uniformly deployed across Laboratory Chemicals. Motivate, empower and educate employees across the matrix in the development of a Customer Focused Quality Culture.
  • Direct the processes of interaction with 3rd Party Auditors, including ISO, or equivalent authorities of other nations, and regulatory compliance agencies.
  • Support Regulatory leaders in fulfillment of their responsibility for product regulatory standards compliance and product certifications.
  • Steer manufacturing compliance activities to insure that all requirements, and all manufacturing practices and record keeping are in full compliance with the applicable regulatory agency requirements.
  • Act continuously to reduce the Cost of Quality, focusing on the relentless pursuit of manufacturing process controls.
  • Manage the oversight and maintenance of metrics to measure performance against Quality objectives.
  • Collaborate with Design Engineering to ensure clear standards of product acceptance and design validation.
  • Reinforce New Product Development by insuring Quality Functional Deployment in the design and launch processes through assignment of adequate resources to Development Teams.
How will you get there?
  • Minimum of a BS/BA is required in chemistry, chemical engineering or a related technical or scientific field.
  • MBA preferred.
  • A minimum of 10 years Quality/Regulatory compliance experience with a minimum of 5 years of experience managing and leading teams. Chemical or Pharmaceutical industries preferred.
  • Global Business Acumen.
  • An experienced change agent who uses multiple change management tools for each situation, team, project and/or geography.

Knowledge, Skills, Abilities
  • Decisive leader who’s able to empower teams and effectively manage a team through a matrix organizational structure.
  • Customer focused and is dedicated to meeting the expectations and requirements of internal and external customers.
  • Results and proactive solution driven with the ability to think critically to overcome potential business hurdles and a track record of delivering results.
  • Communicates to effectively present to all levels of an organization internally and externally
  • Capable to travel up to 30% (including international).
  • Ability to work in a multinational/multicultural environment.

This position has been approved for relocation assistance.

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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