LPG Sr. Director - Quality & Regulatory Affairs
Thermo Fisher Scientific

Job Info

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Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Sr. Director, Quality & Regulatory

When you're part of the team at our company, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help us make substantial contributions to the world.

All of our employees share our important 4-I Values - Integrity, Intensity, Innovation and Involvement. Our capacity to grow year after year is driven by our ability to attract, develop and retain outstanding people who will bloom in our environment and share in our desire to improve people by enabling our customers to make the world healthier, cleaner and safer.

Position Summary:

At Thermo Fisher Scientific , Quality is at the heart of everything we do! The Senior Director, Quality and Regulatory will lead the quality and regulatory strategies across the Laboratory Products Group, which include the Laboratory Equipment, Laboratory Plastics, and Laboratory Chemicals divisions. Reporting to the LSG/LPG Vice President of Quality & Regulatory Affairs, this position has a powerful impact for our customers by providing quality & regulatory leadership and ensuring the appropriate systems and products meet our high standards.

Key Responsibilities:

• Build and drive a Quality and Regulatory framework and strategy for the LPG businesses that supports growth and compliance readiness.
• Ensure compliance to quality and regulatory system requirements (e.g. FDA CFR 820, ISO 13485/9001, IVDR) to meet requirements of regulated and non-regulated sites/products.
• Provide entrepreneurial leadership within the LPG organization to promote a strong quality culture to ensure customer and business expectations are continuously met and exceeded.
• Drive continuous improvement activities and projects to move the organization into a proactive quality mentality.
• Support the commercialization of New Product Introduction, technology transfer, process improvement by working with cross functional team members.
• Actively engage and partner with executive sponsors to develop a value proposition grounded in quality and regulatory that proactively deepens customer relationships and facilitates business growth.
• Ensure a robust talent pipeline by continuously driving the organization's career programs and capabilities.
• Champion and develop quality and regulatory expertise in the organization to ensure products and services are designed, developed, manufactured, and delivered right the first time.
• Manage key business metrics that align with customer expectations to assure year-over-year improvement to enable business growth.

How will you get there?

Education

• B.S. Degree in Engineering or Scientific (STEM) field.

Experience

• A minimum of 15 years of strategic Quality and Regulatory leadership experience in a regulated medical-device manufacturing company.
• A minimum of 7 years experience managing multiple sites.
• Experience with external regulators/notified bodies and requirements such as FDA and ISO.
• Experience working with and managing multiple projects and teams simultaneously across a matrixed organization.
• Medical Device experience required.
• Experience with Lean or Six Sigma improvement systems is helpful.
• 25%-30% travel requirement.

Knowledge, Skills, Abilities

• A decisive leader who is able to inspire and motivate across the quality and regulatory organizations.
• Effectively communicates and presents to all levels internally and externally.

Compensation and Benefits
The salary range estimated for this position based in North Carolina is $175,100.00-$262,700.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
  
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
  
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
  
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
  
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
  

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

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