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.

• 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.

• 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

• 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

• 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