Principal Auditor, Quality Assurance
2 tygodni temu
Principal Auditor, Quality Assurance page is loaded
Principal Auditor, Quality Assurance Apply locations Poland, Warsaw Bulgaria, Sofia UK, Reading Ireland, Dublin time type Full time posted on Posted 19 Days Ago job requisition id JR119953At 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.
Principal Auditor, Quality Assurance
Locations : Poland, Bulgaria, UK, Ireland
What will you be doing as a Principal Auditor in ICON's Quality & Compliance Case Management Team ?
We are looking for you to join our global Case Management team where you will take responsibility for:
- Leading case management of suspected scientific misconduct cases & supporting associated Quality Issues and Serious Breach investigations and reporting.
- Manage ongoing investigations based on the specifics of each individual case in a structured manner and as per relevant work instructions
- Provide ongoing updates on actions and results as needed to the core investigation team and relevant senior management.
- Support ICON functions and client for regulatory reporting such as regulatory reporting documentation as needed.
- Generate internal case summaries and maintain associated case documentation.
- Liaise with clients and regulatory authorities as needed.
- Support ICON Legal for other issues/cases where Q&C support/GxP knowledge is required.
- Liaise with operations for site due diligence requests for information submitted to the Case Management team.
- Assist with external audit and inspection defense as needed.
- Assist with CAPA management as needed.
What do we ask of you?
- Life science degree (Bachelor/equivalent Degree) from an accredited institution
- Extensive experience working in Biopharma industry Quality and/or Compliance
- GCP experience
- Competency in auditing of investigational sites preferred
- Fluency in English (oral, written)
- You are a self-motivated, focused individual with excellent communication skills
If you are interested in a dynamic job and career, please send us your application letter and resume in English.
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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.
Are you a current ICON Employee? Please click here to apply: link
About Us We want to be the Clinical Research Organisation that drives more client projects to market or accelerated decision than anyone else in the industry. 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 great environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.
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