Senior Manager, QMS Governance, Continuous Improvement
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: North Carolina • United States
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Job Level
About the role
- 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
- Guide strategic quality initiatives and support a culture of continuous improvement
- Oversee quality management systems and ensure regulatory compliance
- Enhance customer experience through excellent quality standards
- Collaborate with cross-functional teams to develop and implement quality strategies
- Manage quality assurance and quality control teams
- Build strong partnerships with operations, R&D, and commercial teams
- 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
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
- 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
- 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%
Benefits
- Medical, Dental, & Vision benefits-effective Day 1
- Paid Time Off & Holidays
- 401K Company Match up to 6%
- Tuition Reimbursement – eligible after 90 days!
- Employee Referral Bonus
- Employee Discount Program
- Recognition Program
- Charitable Gift Matching
- Company Paid Parental Leave
- Career Advancement Opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality managementquality assurancequality controldata analysisCAPAchange controlFMEARisk AnalysisRoot Cause Analysiscontinuous improvement
Soft skills
leadershipcollaborationproblem-solvingcommunicationproject managementrelationship buildingstrategic thinkingcustomer satisfactioninvestigation leadershiporganizational skills
Certifications
ASQLean Six Sigma