Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $18 billion and 55,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands – Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services – offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com
Quality and Regulatory Cluster Representative – U.K., Ireland and Netherlands
Netherlands: Landsmeer, Nieuwegein or Breda
U.K.: Milton Keynes, Basingstoke, Hemel Hempstead or Runcorn
Contract Type: Permanent, Full Time
Summary of Key Responsibilities and Function
The purpose of this role is to provide operational direction and leadership for driving the successful implementation of one aligned quality management system for our commercial organization in the region, and then maintain and improve the system. Part of the responsibilities is also to represent the entities in any contact with local authorities responsible for regulation and surveillance of product safety. The person in this role will lead a cluster of countries; U.K., Ireland and Netherlands, and report directly into the Cluster Top Manager. This person is to serve as channel to ensure compliance with internal quality policies and external regulations.
Our commercial organizations are managing sales and marketing, distribution, import, warehousing, customer services and or service operations for diagnostics medical device products. The quality management system is based on the requirements of ISO 13485 and ISO 9001.
External and internal audits
- Manage internal and external quality audits to ensure compliance with ISO 13485 and ISO 9001
- Plan and perform internal audits.
- Maintenance and upgrading ISO certification. Be the main contact point for facing follow-up and re-certification audits by certification body.
Quality System Management
- Lead the implementation of the aligned quality management system in the region
- Maintenance of quality manual and top level procedures. Development and upgrading local work instructions.
- Ensure control of records and documents of the quality management system processes
- Monitor list of approved suppliers and keep supplier evaluations up to date
- Supervise quality related processes, such as:
- Complaint Management
- Servicing and Installation
- Enable collaborative relationships between internal stakeholders with the overall focus of improving customer satisfaction and compliance
Regulatory Affairs and Post Market Surveillance
- Act as liaison with competent authorities for vigilance matters and co-operate with the implementation of the measures from manufacturers, for example, any recalls or rework, and authorities when appropriate
- Manage effectively customer feedback as part of the Post Market Surveillance processes
- Partner with the legal manufacturers in any management of notifications of products by local authorities.
Non Conformities and Corrective Actions
- Drive the process for Corrective and or Preventive Action, CAPA, process.
- Management and tracking of nonconforming products, set up improvement measures.
Management Review and Quality Metrics
- Drive the management review processes. Arrange and participate in the management review meetings and report minutes.
- Ensuring management awareness of the compliance state, and escalation of issues where appropriate.
- Report quality related Key Performance Indicators, (KPI), metrics to relevant stakeholders across the company both locally and globally
Trainings on quality system and procedures
- Encourage quality culture management. Communicate the need for compliance to members of functional areas.
- Develop, manage and monitor training related to the quality system. Training to be carried out in local language.
- A university degree or equivalent in a relevant science subject (e.g. chemistry or pharmacy).
- Quality and compliance knowledge of working with ISO 9001, ISO 13485 and/or FDA 21 CFR 820
- Ability to balance compliance requirements with customer requests and offer appropriate advice
- Capability of working independently, taking responsibility for the management of processes, projects and timelines.
- Capability to lead change and work across departments to implement new procedures and programs.
- Ability to work in a matrix organization
- Multilingual, essential ability to speak and write English and Dutch on a professional level.
- Previous experience from a regulated work environment, preferably within the medical device or diagnostic industry.
- A certification / documented training in auditing of quality systems; ISO 13485 and or ISO 9001.
- Significant experience with numerous years of administering quality systems such as complaint management, CAPA, training, etc.
- Experience in supervising or leading teams to a successful outcome is desired.
- Travels, 10-50%, within the country and region; U.K., Ireland and Netherlands, and further abroad when required.
At Thermo Fisher Scientific, each one of our 55,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.