:
1. 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
2. Responsible for the quality and content of all Risk Management and PMS files for the Division
3. Responsible for the management program to ensure the files are reviewed in line with regulatory requirements
4. Manages the trending of complaints for the division
5. 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
6. 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
7. Cultivates strong working relationships with colleagues in all locations to obtain information required for Risk Management and PMS file compilation
8. Ensures common standards for Risk Management and PMS files across all product groups and locations
9. Manages and communicates progress to the Quality Director and other key stakeholders highlighting areas of risk and uncertainty
10. Plans and executes tasks for self and direct reports to ensure all files are maintained in a current status
11. Anticipates and raises issues that could impact compliance in a timely manner, offering solutions for consideration
12. Supports the Project Management team in relation to Risk Management files for new product development
13. Pro-actively seeks process improvements in line with the company’s PPI Business System
14. Provides metrics as required for relevant business and quality reviews
15. Fulfils the responsibilities of the position as defined in the Divisional Health, Safety and Environmental policies and associated Codes of Practice
16. Role model leader to a team of 4 Quality Associates
17. Effectively hires, manages, coaches and appraises the team to enable them to develop and reach their full potential
18. Creates and maintains a team structure to best meet the needs of the business whilst optimizing resources
Minimum Qualifications:
19. Degree or appropriate qualification in relevant discipline.
20. Knowledge of Risk Management and Post Market Surveillance in the IVD or MD Industry.
21. Ability to effectively manage a team in a quickly changing environment
22. Excellent planning and time management with the ability to adapt to rapid changes in priorities and meeting aggressive timelines
23. Excellent oral and written communication skills
24. Willingness to travel to other MBD sites
Preferred Qualifications and experience:
25. Microbiology product knowledge
26. PPI or continuous improvement qualifications
27. Process automation or AI experience
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