Risk and PMS Manager

Thermofisher Scientific; Basingstoke; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading scientific company in Basingstoke is seeking a Risk and Post Market Surveillance Manager. This role involves ensuring compliance with IVDR regulations by managing risk files, leading a team of Quality Associates, and maintaining quality standards across multiple product portfolios. The ideal candidate will have strong knowledge of Risk Management and the IVD industry, excellent planning abilities, and communication skills. Opportunities for travel and process improvement initiatives will be available.

Benefits

Opportunities for professional development

Innovative and global work environment

Diversity and inclusion programs

Qualifications

• Degree or appropriate qualification in a relevant discipline.
• Knowledge of Risk Management and Post Market Surveillance in IVD or MD industry.
• Ability to effectively manage a team in a quickly changing environment.
• Excellent planning and time management with adaptability.
• Excellent oral and written communication skills.
• Willingness to travel to other MBD sites.
• Microbiology product knowledge.
• PPI or continuous improvement qualifications.
• Process automation or AI experience.

Responsibilities

• Develop and maintain IVDR compliant Risk Management and PMS files.
• Ensure quality of all Risk Management and PMS files.
• Manage trending of complaints for the Division.
• Set direction and goals for the team.
• Manage and communicate progress to stakeholders.
• Anticipate issues that could impact compliance.

Skills

Team management

Planning and time management

Risk Management knowledge

Communication skills

Microbiology product knowledge

Process improvement

Adaptability

Education

Degree in a relevant discipline

Tools

Risk Management software

Process automation tools

Job description

Overview

The Risk and Post Market Surveillance (PMS) Manager reports to the Quality Director and leads a team of Quality Associates. The role is responsible for developing and maintaining IVDR compliant Risk Management and PMS files across MBD's culture media, AST, ID and product portfolios.

Responsibilities

• Driving development and maintenance of IVDR compliant Risk Management and PMS files across MBD's culture media, AST, ID and associated product portfolios.
• Ensuring quality and content of all Risk Management and PMS files for the Division.
• Managing the program to ensure files are reviewed in line with regulatory requirements.
• Managing the trending of complaints for the Division.
• Setting direction and goals for the team; acting as Divisional Risk Management and PMS Lead and expert in risk management file creation.
• Efficiently reallocating and balancing resources in line with changing priorities to keep files current within defined review periods.
• Cultivating strong working relationships with colleagues across locations to obtain information for risk management file compilation.
• Ensuring common standards for Risk Management and PMS files across all product groups and locations.
• Managing and communicating progress to the Quality Director and other key stakeholders, highlighting areas of risk and uncertainty.
• Planning and executing tasks for self and direct reports to keep all files maintained in current status.
• Anticipating and raising issues that could impact compliance in a timely manner, offering solutions for consideration.
• Supporting the Project Management team in relation to Risk Management files for new product development.
• Pro-actively seeking process improvements in line with the company's PPI Business System.
• Providing metrics as required for relevant business and quality reviews.
• Fulfilling responsibilities as defined in the Divisional Health, Safety and Environmental policies and associated Codes of Practice.
• Role modeling leadership to a team of four Quality Associates.
• Effectively hiring, managing, coaching and appraising the team to enable development and full potential.
• Creating and maintaining a team structure to best meet business needs while optimizing resources.

Qualifications

• Degree or appropriate qualification in a 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 ability to adapt to rapid changes in priorities and meet aggressive timelines.
• Excellent oral and written communication skills.
• Willingness to travel to other MBD sites.
• Microbiology product knowledge.
• PPI or continuous improvement qualifications.
• Process automation or AI experience.

Benefits and EEO

As part of Thermo Fisher Scientific, you will work in a challenging, global organization that values performance, quality and innovation. You will have opportunities to contribute to a healthier, cleaner and safer world. 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.