Quality Assurance Manager - Vendor Management

Role: Quality Assurance Manager - Vendor Management

Location: Dublin

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.

As an experienced Quality Assurance Manager and a subject matter expert in supplier/vendor qualification you will co-lead daily operations of ICON Vendor QA program and work within a cross-functional and international team of other Q&C teams.

In this role you will be the expert in performing risk assessment new and existing suppliers, ensuring oversight of the auditing process with ICON internal audit team or outsourced partners as well as providing expert support during sponsor audits and regulatory inspections of ICON.

As Quality Assurance Manager your role will involve:

• Operational oversight of QA Vendor Qualification Activities managed by the Team;

• Providing support and direction to the team in their day-to-day activities. Chair internal calls with the Vendor QA team and contribute as SME to other cross-functional meetings and forums.

• Establishing strong working relationships with other Quality & Compliance groups and internal stakeholders. Attending operational meetings, collecting internal customer input, needs and questions.

• Coordinating and overseeing triage of new vendor requests, directing regular vendor GxP risk assessment activities.

• Contributing to the development and review of key deliverables such as the annual audit schedule, regular operational reports and metrics.

• Coordinating qualification activities with external audit vendors.

• Coordinating development and revision of procedural documents governing Vendor QA activities as well as training material/toolkits for individual involved in these activities. Contributing to continual process improvement.

• Providing feedback and suggestion to support leading the VQ area strategic development. Coordinating operations for a successful execution of strategy and plans to ensure long term success and sustainability of this area.

Although the main focus of this role is to oversee vendor qualification activities, there are also other opportunities to contribute to the many successes of our highly passionate team and support a quality framework that protects patient safety and data integrity.

These include but are not limited to:

• consultation and provision of compliance advice

• performing key audits

• hosting/supporting sponsor audits and regulatory inspections

• process review and engineering

As a Quality Assurance Manager you will need:

• Experience in QA, with GxP auditing

• Robust experience in GCP; additional experience in other GxP areas, preferred (e.g. GLP, GPvP, GMP, GDP)

• An understanding of vendor oversight and qualification strategies for regulated Vendors

• Strong operational and functional management experience

• Demonstrated strength in agile working principles, methodologies, and team structures

• display initiative and a problem solving attitude. You need to be able to think out-of-the-box and not be afraid of being innovative and flexible

• Expert knowledge with sponsor audit or inspection management

• Knowledge of CRO / Healthcare / Pharmaceutical Vendor Management Quality Assurance activities preferred

• Ability to travel 30-35%

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.

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