Sr. Manager, QMS Governance & Continuous Improvement

Thermo Fisher Scientific•Durham, NC

3d•Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. As a member of the site leadership team, you'll support quality initiatives that deliver consistent product excellence while meeting business objectives. You'll develop quality professionals, lead investigations, and implement data-driven solutions that enhance our quality systems and customer satisfaction. As a Senior Manager of Quality at Thermo Fisher Scientific, you will guide strategic quality initiatives and support a culture of continuous improvement across our organization. You'll oversee quality management systems, ensure regulatory compliance, and enhance customer experience through excellent quality standards. Working closely with cross-functional teams, you'll develop and implement quality strategies that support our mission of enabling customers to make the world healthier, cleaner, and safer. In this role, you'll manage quality assurance and quality control teams while building strong partnerships with operations, R&D, commercial teams, and customers. You'll guide process improvements through Practical Process Improvement (PPI) methodologies and risk-based approaches. Your leadership will be essential in maintaining inspection readiness, managing customer relationships, and ensuring compliance with global regulatory requirements.

Requirements

Advanced Degree plus 6 years of experience, or bachelor’s degree plus 8 years of experience in pharmaceutical, medical device, or regulated life sciences industry
5+ years of quality management/leadership experience
Expert knowledge of global quality standards (ISO 13485, ISO 9001, FDA 21 CFR 820, EU MDR/IVDR)
Strong understanding of quality management systems and GMP requirements
Demonstrated experience leading quality investigations, CAPA, and change control processes
Experience implementing continuous improvement initiatives
Experience with quality tools including FMEA, Risk Analysis, and Root Cause Analysis
Excellent project management and cross-functional leadership abilities
Strong data analysis and problem-solving capabilities
Excellent written and verbal communication skills
Ability to build collaborative relationships at all levels
Experience hosting regulatory inspections and customer audits
Proficiency with quality management software systems
Ability to travel up to 25%

Nice To Haves

Preferred Fields of Study: Science, Engineering, Chemistry, or related technical field
Professional certifications desired (ASQ, Lean Six Sigma, etc.)

Responsibilities

Guide strategic quality initiatives
Support a culture of continuous improvement
Oversee quality management systems
Ensure regulatory compliance
Enhance customer experience through excellent quality standards
Manage quality assurance and quality control teams
Build strong partnerships with operations, R&D, commercial teams, and customers
Guide process improvements through Practical Process Improvement (PPI) methodologies and risk-based approaches
Maintain inspection readiness
Manage customer relationships
Ensure compliance with global regulatory requirements