Senior Manager, Quality Assurance

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.

Roles and Responsibilities for the Senior Manager, Quality Assurance:

• Recognize, exemplify and adhere to ICON's values which center on Integrity, Accountability & Delivery, Collaboration, Partnership and Own IT@ICON

• Manage Projects, People and/or Audits relevant to the Functional area as appropriate for the position.
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As  a  Manager, the  employee  is  expected to  recognize  the  importance  of  and create a  culture  of process  improvement  with  a  focus  on  streamlining  our  processes  adding  value  to  our  business and meeting client needs.
• Support development, implementation and maintenance of Quality Management System in conjunction with QA Leadership Team in both consultative and leadership role as required.
• Identify changes and be aware of pending changes to GXP industry regulations and guidance’s worldwide.
• Adapt plans and priorities to meet operational challenges or provide advice to others in their area of expertise.
• Proactively flag potential issues to regional Director/Senior Director QA and manage remediation of those issues as applicable.
• Ensure that Sponsor audits and Regulatory inspections are effectively executed and provide support and direction during the hosting of such audits/inspections as necessary.
• Provide technical/SME guidance to employees/colleagues and/or customers.
• Support regular and random QA audits of the ICON quality system on a site/regional/global basis in order to evaluate the quality system against the requirements of appropriate regulations and applicable guidelines or standards.
• Ensure that quality activities are conducted, managed and reported according to relevant timeframes and plans and liaise with appropriate managers as necessary.
• Provide expertise and leadership in Quality Compliance to the wider organization and ensure that all personnel are aware of the ICON requirements for quality.
• Act as a key ICON Q&C contact for designated clients to support partnerships from a quality perspective.
• Effectively manage the tracking, analysis and reporting of defined Q&C quality and performance metrics, and utilize/present as relevant.
• Impacts the results of the area of responsibility through the team’s ability to meet quality, volume and timelines objectives and/or inputs to decisions in their area of specialization.
• Actively participate in or lead process improvement initiatives with the Q&C teams/ICON teams and ensure achievement of high quality standards.
• Identifies and resolves technical and/or operational issues, drawing on company policies and guidelines and identifying exceptions for further review.
• To undertake other reasonably related duties as may be assigned from time to time.
• Skills required would include: Attention to details, Communication, problem-solving, influencing, team work, client-facing, multi-tasking, time management.
• Travel (up to 25%) domestic and/or international.

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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.