Thermo Fisher Scientific
Sr Manager, Supplier Quality
- Location
- Rochester, NY (NY)
- Posted
- Posted today (employer shows the date only)
- Source
- Workday (employer's applicant tracking system)
- Category
- Manufacturing/Quality
- Industry
- Pharma/Biotech
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Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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.
What will you do?
As a Senior Manager of Supplier Quality, you'll guide our global performance management program and elevate our supplier quality standards. You'll lead a team of Supplier Quality Engineers and work closely with cross-functional partners to support continuous improvement and strategic supplier development. This role offers the opportunity to contribute to critical quality initiatives, develop partnerships with key stakeholders, and facilitate problem-solving activities that address non-conformances.
Key responsibilities include:
· Lead and develop the Supplier Quality team; build talent and succession plans, strengthen organizational capabilities, and manage performance against business priorities.
· Manage team performance through ongoing coaching and formal performance reviews; identify development needs and support individual development plans.
· Own the supplier quality framework across the supplier lifecycle, from initial assessment and qualification through ongoing monitoring and improvement.
· Assist in setting the direction for the Supplier Quality organization, translating business and quality priorities into team objectives, operating plans, and clear accountability.
· Accountable for regulatory compliance and supplier risk management, ensuring risks are assessed, prioritized, and addressed across the supply chain.
· Define supplier quality metrics and review performance trends to guide priorities, resource allocation, new technologies, and process improvements.
· Drive the adoption of technologies and processes that strengthen supplier oversight and support material qualification, product changes, and sustaining engineering.
· Oversee quality improvement programs that deliver measurable gains in supplier performance and product quality.
· Using data analysis, quality tools, project management, and professional skills, lead initiatives to enhance supplier performance and product quality.
· Build strategic alignment across Sourcing, Manufacturing, Product Engineering, Global Technical Support, Operations, and Commodity Management to resolve systemic supplier quality challenges.
· Develop senior-level supplier relationships and engage supplier leadership in addressing systemic issues and improving quality capability.
· Plan and lead supplier quality audits, document findings, and follow up on corrective actions.
· Own the supplier audit program and corrective action governance, ensuring findings are addressed and recurring issues are prevented.
· Oversee the supplier nonconformance and corrective action system, ensuring timely containment, effective root cause analysis, and sustained corrective and preventive actions.
· Guide continuous improvement priorities across the supplier network, aligning projects and resources with business needs and quality risks.
· Maintain and analyze supplier quality and performance metrics to identify trends, investigate non-conformances, and conduct root cause analysis.
· Lead continuous improvement projects that improve supplier performance and product quality.
- undefined
How will you get there?
- Bachelor’s Degree plus 8-10 years of experience, or Advanced Degree plus 6 years of experience in medical device/pharmaceutical industry quality or regulatory affairs roles
- Preferred fields of study: Engineering, Operations Management, or Biological Sciences
- Quality Lead Auditor certification preferred
- Minimum 3 years people management experience
- Strong knowledge of ISO 13485 and 21 CFR Part 820 regulations
- 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
- Willingness to travel up to 50% domestically and internationally
- Ability to work in manufacturing environments requiring PPE including cleanroom gear
…
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