Role: Quality Assurance Manager - Technology

Location: Flexible and Remote from any European location

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

We are looking for an experienced Quality Assurance Manager to join our specialist team, to help support our business areas with corporate systems compliance, complex architecture and interoperability as well as data governance and data integrity.

As Quality Assurance Manager your role will involve:

• Providing cross-functional Quality Assurance expertise, supporting all areas of Technology and Information Compliance.
  
• Responsible for review and approval of computerized systems validation and/or qualification deliverables to ensure documentation supports a compliant state .
  
• Supporting efforts for standardization and advancement of validation / qualification methodologies in support of software, equipment with software and medical devices used in a clinical setting.
  
• Conducting internal computerized system validation audits and vendor assessments/qualifications.
  
• Supporting technology focused sponsor audits and inspections.
  
• Providing guidance to technology and information management groups to ensure the business understands applicability of associated published regulatory guidance or regulations concerning GCP, GLP, GMP, 21CFR Part 11, and Annex 11.
  
• Supporting training activities focused on advancing Systems Compliance SMEs across Quality and Compliance.
  
• Developing and fostering positive relationships with business unit customers to ensure a common understanding, approach and appreciation for computerized systems validation (CSV).
  
• Consulting and providing risk-based recommendations for the development, testing / validation and implementation of computerized systems across the business.
  
• Performing quality reviews of SOPs and WIs that effect the direction and process of systems compliance initiatives.
  
• Participating in related industry training, conferences, and professional organizations in order to keep the team current and updated with the most recent IT and computer systems best practices. This includes researching, presenting, and distributing information within and external to the Quality and Compliance team.
  
• Building effective working relationships with key technology owners and user groups; proactively providing quality input to system design and procurement.
  

As a Quality Assurance Manager you will need:

• Educated to degree level
  

• Experience specific to the application or support of software validation and compliance efforts.
  
• Experience in QA, with GxP auditing, systems compliance, and SOP development
  
• An understanding of validation and qualification strategies for regulated systems including software and medical devices used in clinical settings.
  
• Demonstrated strength in agile working principles, methodologies, and team structures
  
• Expert knowledge with audit or inspection management
  
• Ability to travel as needed to vendor and/or internal sites
  

Benefits of Working in ICON:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

Are you a current ICON Employee? Please click here to apply: link