Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Position Summary:
The Risk and Post Market Surveillance (PMS) Manager will report into the Quality Director. The role holder will lead a team of Quality Associates and is responsible for leading the development and maintenance of IVDR compliant Risk Management and PMS files across MBD’s culture media, AST, ID and associated product portfolios. You will need to work with multi-functional teams across 6 sites in the US and Europe, and will be the key point of contact for stakeholders in QA/RA, Project Management and Brand Management. The role holder will be responsible for the quality and content of all Risk Management and PMS files for the Division and will ensure defined Standard Operating Procedures (SOP’s) are followed and templates in place.
Responsibilities:
- Responsible for driving the development and maintenance of IVDR compliant Risk Management and PMS files across MBD’s culture media, AST, ID and associated product portfolios
- Responsible for the quality and content of all Risk Management and PMS files for the Division
- Responsible for the management program to ensure the files are reviewed in line with regulatory requirements
- Manages the trending of complaints for the division
- Sets the direction and goals for the team Acts as the Divisional Risk Management and PMS Lead and expert in relation to Risk Management and PMS file creation
- Efficiently re-allocates and balances resource as required and in line with changes in priorities to ensure all files are maintained as current within the review periods defined
- Cultivates strong working relationships with colleagues in all locations to obtain information required for Risk Management and PMS file compilation
- Ensures common standards for Risk Management and PMS files across all product groups and locations
- Manages and communicates progress to the Quality Director and other key stakeholders highlighting areas of risk and uncertainty
- Plans and executes tasks for self and direct reports to ensure all files are maintained in a current status
- Anticipates and raises issues that could impact compliance in a timely manner, offering solutions for consideration
- Supports the Project Management team in relation to Risk Management files for new product development
- Pro-actively seeks process improvements in line with the company’s PPI Business System
- Provides metrics as required for relevant business and quality reviews
- Fulfils the responsibilities of the position as defined in the Divisional Health, Safety and Environmental policies and associated Codes of Practice
- Role model leader to a team of 4 Quality Associates
- Effectively hires, manages, coaches and appraises the team to enable them to develop and reach their full potential
- Creates and maintains a team structure to best meet the needs of the business whilst optimizing resources
Minimum Qualifications:
- Degree or appropriate qualification in relevant discipline.
- Knowledge of Risk Management and Post Market Surveillance in the IVD or MD Industry.
- Ability to effectively manage a team in a quickly changing environment
- Excellent planning and time management with the ability to adapt to rapid changes in priorities and meeting aggressive timelines
- Excellent oral and written communication skills
- Willingness to travel to other MBD sites
Preferred Qualifications and experience:
- Microbiology product knowledge
- PPI or continuous improvement qualifications
- Process automation or AI experience
Join Thermo Fisher Scientific Inc. today and be part of a diverse and inclusive community dedicated to making the world healthier, cleaner, and safer.