Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Join our Supplier Quality team and contribute to excellence at Thermo Fisher Scientific! As a Senior Manager of Supplier Quality, you will lead and develop a high-performing team of Supplier Quality Engineers, driving accountability, engagement, and continuous improvement across the function. You will play a critical role in shaping and executing our global supplier quality strategy while ensuring alignment with business objectives and regulatory expectations.

In this role, you will be responsible for ensuring that suppliers are qualified, approved, and continuously monitored in accordance with applicable global regulations, internal procedures, and quality system requirements. You will oversee supplier lifecycle management, including qualification, auditing, performance evaluation, and remediation activities, ensuring robust controls are in place to mitigate risk and maintain compliance.

You will collaborate closely with cross-functional partners—including Procurement, Manufacturing, R&D, and Regulatory Affairs—to support new product introductions, supplier selection, and ongoing supplier development. This role also involves leading complex investigations, driving effective corrective and preventive actions, and ensuring timely resolution of supplier-related non-conformances.

Additionally, you will guide the implementation and continuous improvement of supplier quality processes, promote a culture of quality and compliance, and support global harmonization initiatives across regions and business units.

REQUIREMENTS:

• Advanced Degree plus 6 years of experience, or Bachelor’s Degree plus 8 years of experience in medical device/pharmaceutical industry quality or regulatory affairs roles
• Preferred Fields of Study: Engineering, Operations Management, or Biological Sciences
• Minimum 3+ years of direct people leadership experience, including coaching, performance management, and team development
• Demonstrated experience leading and developing high-performing teams in a global and/or matrixed environment
• Strong knowledge of ISO 13485 and 21 CFR Part 820 regulations
• Deep understanding of supplier qualification, approval, and re-evaluation processes in compliance with global regulatory requirements and internal quality procedures
• Experience ensuring supplier controls align with regulatory expectations, including supplier audits, quality agreements, and risk-based qualification methodologies
• Experience with global regulatory agencies (FDA, IVDR Notified Bodies, PMDA, ANVISA, Health Canada)
• Proficiency in Six Sigma methodologies (8D, FMEA, DMAIC, Value Stream Mapping, Pareto Analysis)
• Statistical analysis skills (SPC, DOE, sampling)
• Experience with quality management systems (SAP, TrackWise)
• Strong understanding of supplier performance management principles
• Excellence in oral and written communication, with fluency in English
• Experience implementing global harmonization initiatives
• Experience managing matrix organizations across diverse cultures
• Strong project management and strategic planning capabilities
• Ability to build and maintain relationships with internal/external stakeholders
• Ability to work in manufacturing environments requiring PPE including cleanroom gear
• Technical proficiency with IT databases and digital tools
• Problem-solving mindset with experience implementing effective solutions

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Other

Relocation assistance may be provided.

Must be legally authorized to work in the United States now and in the future, without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.