Sr. Director, Quality Systems & Design Quality
Thermo Fisher Scientific

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

The Sr. Director of Quality Systems and Design Quality will be responsible for the Life Sciences Group (LSG) quality system and design quality strategies to support the business. The incumbent will be part of the Thermo Fisher Scientific LSG & LPG Quality and Regulatory team based in the U.S. and will serve as an active leader of Quality organization supporting the growing LSG businesses.

Life Sciences (LSG) Group, a Group within Thermo Fisher Scientific, we deliver - industry-leading life sciences tools and solutions to advance scientific discovery, enable customers in applied markets and improve global health outcomes.

Position is based remotely, within the United States of America.

Discover Impactful Work:

Reporting to the Vice President of Quality and Regulatory Affairs, this position is responsible for ensuring global quality systems follow all applicable regulations. This role will provide Quality Systems oversight within LSG, ensuring the requirements associated with Strategic Quality Planning, Regulation Monitoring, QMS integration / harmonization / continuous improvement activities, Service and Repair, Distribution, Management, Post Market Processes (Complaints, Surveillance, Field Actions) and Design Quality programs are optimally established and maintained according to business needs while meeting customer, colleague and regulatory requirements.

The Sr. Director, Quality Systems and Design Quality will:

• Enable the design quality function to deliver new products that meet customer, operational and regulatory requirements.
• Ensure Product Legislation Compliance requirements (REACH, PFAS, etc) are monitored, investigated and actioned to meet global requirements.
• Ensures a robust service and repair and distribution quality program meets internal and external compliance requirements.
• Enables the global distribution quality team to drive a compliant distribution program for our products between Thermo Fisher Scientific sites as well as to our customers.
• Represent the organization with Regulatory agencies and professional organizations to ensure the Quality Management System remains current and driven. Is knowledgeable of external trends and incorporates accordingly.
• Promote continuous improvement (demonstrating PPI Business Processes) and harmonization to drive operational and global Quality systems efficiencies to meet customer and global regulatory requirements.
• Enables and drives a robust digital transformation roadmap (including AI) for Quality & Regulatory
• Provides global quality system leadership to ensure internal policies and customer expectations are met.
• Coordinates company-wide processes for quality and regulatory reviews, as well as long-term planning.
• Directly partners with the various Quality and Regulatory, Operations, R&D, and Commercial organizations.

Minimum Qualifications:

• Bachelor's degree in a science or related field, or equivalent experience, required.
• Master's or advanced degree preferred.
• 10+ years experience leading quality teams.
• 15+ years experience in quality roles of increasing responsibility, impact, and scope within a manufacturing/new product development/diagnostic environment.
• Proven experience with applicable FDA, European and other relevant clinical/regulatory requirements, including ISO 13485, IVDR/MDR, 21CFR 820 Quality System Regulation, MDSAP.
• Six Sigma Black Belt strongly preferred.
• Demonstrated and impactful project management and people leadership skills

Skills/Abilities

• Strong interpersonal and collaborative skills, establishing positive and productive relationships
• Agility to manage multiple complex projects simultaneously
• Ability to interpret trends and data, translating the information into actions, outcomes and improvements
• Strong verbal and written communication skills
• Self-starter and independent critical thinker, with the ability to work autonomously
• Ability to lead from and across a globally matrixed organization

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Compensation and Benefits
The salary range estimated for this position based in Wisconsin is $192,700.00-$289,000.00.

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

This job has expired.