Sr. Manager Quality Sterility Assurance
Thermo Fisher
Summary
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.
Job description
Discover Impactful Work
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.
A Day in the Life
- Manage quality assurance and quality control teams while building 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, and ensure compliance with global regulatory requirements.
- As a member of the Quality Leadership Team, support quality initiatives that deliver consistent product excellence while meeting business objectives.
- Develop quality professionals, lead investigations, and implement data-driven solutions that enhance quality systems and customer satisfaction.
Education/Experience
- 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 required.
- Preferred Fields of Study: Science, Engineering, Chemistry, or related technical field.
- Professional certifications desired (ASQ, Lean Six Sigma, etc.).
- 5+ years of quality management/leadership experience.
- Experience hosting regulatory inspections and customer audits.
- Experience implementing continuous improvement initiatives.
- Experience with quality tools including FMEA, Risk Analysis, and Root Cause Analysis.
Knowledge, Skills, Abilities
- 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.
- 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.
- Proficiency with quality management software systems.
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
- Experience hosting regulatory inspections and customer audits
- Experience implementing continuous improvement initiatives
- Experience with quality tools including FMEA, Risk Analysis, and Root Cause Analysis
- 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
- 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
- Proficiency with quality management software systems
Benefits
- Medical, Dental & Vision
- Health Incentive Programs
- Employee Assistance Program
- Family Support Programs
- Commuter Benefits
- Tuition Reimbursement
- Paid Time Off
- Paid Holidays
- Paid Parental Leave
- Accident Insurance
- Life Insurance
- Short & Long-Term Disability
- 401(k) Retirement Savings Plan
- Employee Stock Purchase Plan
- Annual Incentive Bonus
Company overview
Thermo Fisher Scientific is a global leader in serving science, with annual revenue of approximately $40 billion. The company provides a comprehensive portfolio of analytical instruments, equipment, reagents and consumables, software, and services for research, analysis, discovery, and diagnostics. Their mission is to enable customers to make the world healthier, cleaner, and safer by accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, and increasing laboratory productivity. Thermo Fisher serves pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions, and government agencies worldwide. The company operates through four business segments: Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products and Services.