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Principal Quality Professional - GxP Vendor Management (Remote, EU)

Employer
ICON - EMEA
Location
Dublin, Ireland, Homeworking
Salary
Competitive
Start date
19 Aug 2022
Closing date
25 Aug 2022

View more

Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

Role: Principal Quality Assurance Professional - Vendor management

Location: Flexible within Europe - with Remote working

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 a Principal Quality Assurance Professional to join our Vendor QA team.

Our Vendor QA group is a fabulous team of GxP QA professionals who oversee the quality assurance assessment, onboarding, oversight, qualification and tracking of regulated vendors. Teamwork, can-do spirit and collaboration are the hallmarks of our group. We have fun, laugh, pull together and get it done.

With hundreds of vendors from all GxP disciplines, there is no shortage of excitement and opportunity from which to learn and grow. Consider bringing your talent to this dynamic group.

As Principal Quality Professional you will:

  • Performing risk assessments for new vendor requests in compliance with regulatory expectations to determine QA qualification requirements for onboarding.
  • Liaising with auditors (internal & external), sponsors, procurement, operational staff and vendors to develop Audit Scope / Plan and to coordinate qualification, surveillance and for-cause audits of vendors.
  • Reviewing vendor Audit Reports, Observations along with auditee responses to ensure compliance of vendors and determine qualification status.
  • Executing Vendor CAPA management (tracking, follow-up, evidence review and closure).
  • Developing / archiving / maintaining audit documentation e.g. audit scope, audit certificates, ICON official audit records, CAPA documentation.
  • Assisting with the evaluation, development and issuance of yearly Supplier Audit Schedule and quarterly revisions/updates
  • Supporting regulatory inspection or sponsor audit requests for vendor qualification evidence.
  • Contributing to team meetings, respond to regulatory related queries received by Vendor QA and escalate any issues to relevant management for action.
  • Travel is not expected except in rare or unusual circumstances.


Experience, knowledge. skills requirements:
  • Thorough knowledge of GxP regulations for the conduct of clinical trials (GCP essential; some/all of GLP, GMP, GVP, GDP, Medical Devices, CSV desirable).
  • Familiarity with all aspects of vendor management / oversight.
  • Excellent planning and organizational skills with the ability to multi-task and prioritize effectively.
  • Articulate communication and writing skills.
  • Effective and efficient problem solving.
  • Ability to own assigned tasks and drive to completion; ability to work independently.


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

Company

We offer a full range of consulting, clinical development and commercialisation services from a global network of offices in 46 countries

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

Find Us
Telephone
01628 496300
Location
3rd Floor
Marlow International
Marlow
Buckinghamshire
SL7 1YL
United Kingdom
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