The Global Quality & Regulatory Director will lead the Quality function across the Laboratory Consumables Division (LCD) of Thermo Fisher Scientific. The Global Quality & Regulatory Director reports to the Vice President of Global Operations for the division, and is responsible for Quality and Regulatory compliance at all manufacturing sites. Reporting into this role includes the site Quality leaders and their respective teams in sites throughout the United States, United Kingdom, Denmark, Finland, Russia, and Mexico, as well as two regulatory managers in Rochester, New York.
Job Duties and Responsibilities:
- Leads the Quality Function through supervisory management of Regional / Site Quality Managers and organizations, including establishing organizational structures and Quality policies that are uniformly deployed across LCD.
- Oversees the development and deployment of Quality Management Systems (QMS) at all locations, acting to insure site-to-site harmonization of documented systems that comply with the requirements of all regulatory standards and agency authorities to which LCD is accountable – including ISO, and corresponding authorities of other nations, FDA,EU, IVD, Health Canada and similar bodies.
- Directs the processes of interaction with 3rd Party Auditors, including ISO, or equivalent authorities of other nations, and regulatory compliance agencies. Personally engages in direct inter-action in audits and investigations when required. Acts to build consensus and establish common ground in regard to regulatory challenges, and serves as the chief spokesperson in establishing resolution of issues with such agencies and authorities.
- Supports Regulatory leaders in fulfillment of their responsibility for product regulatory standards compliance and product certifications. Directs manufacturing compliance activities to insure that GMP requirements, and all manufacturing practices and record keeping are in full compliance with the applicable regulatory agency requirements.
- Acts continuously to reduce the Cost of Quality, focusing on the relentless pursuit of manufacturing process controls.
- Leads, motivates, and teaches Associates in the development of a Customer Focused Quality Culture that is based on industry-leading product quality, closed-loop customer quality feedback, and internally-focused Root Cause Analysis and Preventative Actions through x-functional teams and other methods.
- Serves as the organizational control point for resolving customer claims related to product quality issues. Inter-acts cross-functionally within the Division to accomplish this responsibility and with Corporate Risk Management and Legal in regard to large claims, questionable claims, or product liability issues.
- Interacts with Sourcing Leaders as required to ensure that the Supplier Performance Management Metrics are established to reflect the expectations.Collaborates with Supplier Quality Engineering to develop methods to reduce the cost of Quality Surveillance
- Manages the oversight and maintenance of metrics to measure performance against Quality objectives. Uses the metrics to define and champion an on-going series of continuous improvement actions and initiatives.
- Interacts with Design Engineering to ensure clear standards of product acceptance and design validation.
- Supports New Product Development by insuring Quality Functional Deployment in the design and launch processes through assignment of adequate resources to Development Teams. Personally engages in such processes as required to ensure successful accomplishment of the product vitality objectives.
- Drives productivity by interacting cross-functionally as required to optimize the results of PPI-Business System initiatives, across the Division. Performs all job duties in a safe manner and obeys all safety policies and procedures.
- Performs as a Role Model Leader, acting in compliance with the Thermo Fisher Code of Ethics Administer the Division’s overall Quality System, management of the Company’s Quality Assurance and Quality Control departments, assuring that all Company policies and practices meet or exceed all regulatory requirements.
- Minimum of a BS/BA is required in a related technical or scientific field
- MBA preferred.
- 10+ years Quality/Regulatory compliance experience with 5+ years management
- Experience in Medical Device or Pharmaceutical manufacturing is preferred.
- Experienced with application of FDA and ISO quality standards in a government regulated industry.
- Direct experience with FDA and Notified Body inspections.
- Experience with initial regulatory submissions as well as periodic submission of updates.
- Require up to 25% travel including international.
- Ability to work in a multinational/multicultural environment.
- Global business acumen.
- Courageous, outgoing, analytical, disciplined, agile, team oriented
- Ability to effectively lead and manage a team through influence in a matrix organizational structure
- Results and proactive solution driven, the ability to think critically to overcome potential business hurdles to complete tasks
- Proactively cooperate with other departments
- Communications to effectively present to all levels of an organization internally and externally.
This position has been approved for relocation assistance.