Manager, Product & Client Quality
Thermo Fisher
Summary
As a Quality Manager at Thermo Fisher Scientific, you will contribute to excellence across our quality management systems while enabling our mission to make the world healthier, cleaner and safer. You will guide quality initiatives, support continuous improvement, and cultivate a culture of compliance and operational excellence. Working collaboratively across functions, you will ensure adherence to regulatory requirements while maintaining the highest quality standards for our products and services.
Job description
Description
As a Quality Manager at Thermo Fisher Scientific, you will contribute to excellence across our quality management systems while enabling our mission to make the world healthier, cleaner and safer. You will guide quality initiatives, support continuous improvement, and cultivate a culture of compliance and operational excellence. Working collaboratively across functions, you will ensure adherence to regulatory requirements while maintaining the highest quality standards for our products and services.
Product Quality and Management Reviews
- Strategically plan and prioritize Annual Product Quality Reviews (APRs) to meet assigned timelines.
- Coordinate and compile management review presentations with subject matter experts (weekly and monthly meetings as needed).
- Author and manage reports, decisions, and action items arising from APQRs and management reviews.
- Support site Change controls, CAPAs and Deviations as needed.
- Support site Quality Plan and track KPIs & metrics with applicable stakeholders.
- Lead Quality Management System improvements and cross-functional process optimization, including implementation and optimization of QMS systems.
Client Quality Relations
- Serve as the primary Quality representative for assigned clients.
- Coordinate client-related quality commitments and action items, track progress, and escalate overdue or significant quality issues through established processes (CCRs, Deviations, Complaints, Batch Release etc.).
- Monitor product quality trends, risks, and key performance metrics.
- Support client quality meetings, audits, and requests for quality information as assigned.
- Partner with Manufacturing, Quality, Regulatory Affairs, and Supply Chain to drive issue resolution and continuous improvement.
- Represent Quality during Business Reviews, Supplier Operations Meetings, and strategic customer engagements as needed.
- Serve as the bridge between customers and internal stakeholders to ensure alignment on quality expectations and product performance.
Quality Culture
- Participate in site's Quality Culture Program and promote Quality Culture across site.
Requirements
- Bachelor's Degree plus 4-5 years of quality experience in pharmaceutical, medical device or regulated industry
- Preferred Fields of Study: Chemistry, Biology, Engineering, Pharmacy, or related scientific/technical field
- Comprehensive knowledge of quality management systems and regulations (ISO 9001, ISO 13485, FDA QSR/cGMP)
- Strong understanding of quality tools and methodologies (CAPA, risk analysis, FMEA, root cause analysis)
- Experience supporting internal/external audits and regulatory inspections
- Demonstrated ability to develop and mentor quality teams
- Successful experience implementing and improving quality systems
- Skill in cross-functional collaboration and stakeholder management
- Strong analytical and problem-solving capabilities
- Clear written and verbal communication skills
- Proficiency with quality management software (TrackWise, Document Control Systems)
- Experience with continuous improvement methodologies (Lean, Six Sigma)
- Ability to promote quality culture across all levels
- Focus on customer needs and ability to manage customer/supplier relationships
- Up to 20% travel may be required
Benefits
- Medical, Dental & Vision
- Health Incentive Programs
- Employee Assistance Programs
- Family Support Programs
- Commuter Benefits
- Tuition Reimbursement
- Paid Time Off
- Paid Holidays
- Paid Parental Leave
- Accident Insurance
- Life Insurance
- Short-Term Disability Insurance
- Long-Term Disability Insurance
- 401(k) Retirement Plan
- Employee Stock Purchase Plan
- Annual 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.