Sr. Manager Supplier Quality

Work Schedule

Environmental Conditions

Job Description

Heres a revised version of your job description with stronger emphasis on leading a team and ensuring supplier qualification in compliance with applicable regulations and procedures while keeping the tone aligned with Thermo Fisher:

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

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 partnersincluding Procurement Manufacturing R&D and Regulatory Affairsto 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 Bachelors 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