When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, and you’ll be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you’ll find the resources and opportunities to make significant contributions to the world.
The Senior Global Quality Leader will lead the global Quality function across the Customer Channels Group (CCG) of Thermo Fisher Scientific. CCG distributes over 30,000 medical devices in its portfolio, including private label and manufacturer branded products, utilizing a global network of distribution centers, field and direct sales force, print and digital catalogs and a state-of-the-art website.
Responsible for ensuring the Quality Management Systems (QMS) meet all applicable regulatory requirements and ISO standards. Provide leadership, guidance and oversight to regional Quality leaders in the US, Canada and Europe and to site leaders at almost 30 sites worldwide.
The Senior Global Quality Leader will work with key internal and external stakeholders globally to improve customer satisfaction and optimize performance and will routinely interact with and serve as the primary contact for our customers and suppliers with respect to Quality-related matters. Act as the CCG representative to the Thermo Fisher Scientific QARA Council to ensure that the business needs of CCG are represented and company-wide functional issues are supported. This position reports to the Vice President and General Counsel of CCG.
- Lead the Quality function and regional Quality leaders and site leaders across the globe, including establishing organizational structures and policies that are uniformly deployed across CCG. Lead, motivate and teach associates in the development of a customer-focused Culture of Quality that is based on industry-leading practices.
- Oversee the development and deployment of Quality Management Systems (QMS) at all locations. Ensure site-to-site harmonization of documented systems that comply with the requirements of all regulatory standards and agency authorities to which CCG is accountable, including ISO 9001/13485, and appropriate regulatory authorities, including but not limited to, FDA, Health Canada and similar bodies.
- Directly interact with third party auditors, including ISO, or equivalent authorities of other nations, regulatory compliance agencies and customer auditors. Personally engage in audits and investigations when required. Build consensus and establish common ground in regard to regulatory challenges, and serve as the chief spokesperson in establishing resolution of issues with agencies, authorities and customers.
- Work with the operations team to improve, compliance, safety and efficiency of our sites and operations.
- Serve as the Management Representative having the authority over and responsibility for: a) Ensuring that quality system requirements are effectively established and effectively maintained; and b) Reporting on the performance of the quality system to management with executive responsibility for review.
- Support the commercial organization and directly interact with customers, serving as the chief spokesperson for the Quality organization in Quality-related commercial discussions.
- Interact with sourcing leaders to develop and implement supplier qualification and maintenance processes and performance management metrics and directly interact with suppliers as necessary to address Quality-related matters.
- Act continuously to reduce the cost of Quality, focusing on the provision of appropriate system and process controls.
- Operate within a matrix organization and serve as the coordinator across divisions, functions and departments in order to resolve Quality issues and improve performance.
- Work with Risk Management and Legal to promptly communicate and escalate material claims and issues.
- Establish and maintain metrics to measure performance against Quality objectives. Use the metrics to define and champion an on-going series of continuous improvement actions and initiatives.
- Leverage our PPI Business System to drive productivity and continuous improvement across the Quality function.
- Perform all job duties in a safe manner and obey all safety policies and procedures.
- Perform as a Role Model Leader, acting in compliance with the Thermo Fisher Code of Conduct and adopting our 4-I Values in everything you do.
- Bachelor of Science or Art’s Degree in related technical or scientific field.
- 10+ years of experience in Quality compliance.
- 5+ years of managing others in a matrix organizational structure.
- Application of 21 CFR Part 820 Quality System Regulations (QSR), ISO 9001/ISO 13485 or similar experience.
- Demonstrated experience with FDA and Notified Body inspections.
- Willingness and ability to travel from 25-50%, including international.
- MBA or other advanced degree.
- Medical Device or Pharmaceutical distribution experience.
- Ability to work in a multinational/multicultural environment with strong global business acumen.
- Excellent written and verbal communication skills to effectively present to all levels of an organization internally and externally and proactively work and cooperate with other departments, suppliers and customers.
- Demonstrated success with being results and proactive solution driven, with strong ability to think critically to overcome potential business hurdles to complete tasks.
- Courageous, outgoing, analytical, disciplined, agile, and team oriented.
This position has been approved for Relocation Assistance.
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