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.

Manager, Quality Assurance- Whitesboro, NY- onsite

Responsible for enforcing an efficient and compliant auditing program according to senior management-approved Quality Assurance Operating Plan and company SOPs (Standard Operating Procedures), GLP , bioanalytical guidelines and clinical trials regulations.  Provides expertise on the design, implementation and development of GxP, systems, processes and procedures. Manages QA auditors’ team to ensure contracted and internal audits are performed, findings reported to management and/or clients, and corrective actions evaluated.

Responsibilities: 

• Participates in the selection, hiring and training of new QA staff.
• Performs personally and/or ensures new and updated GLP SOPs are reviewed by QA
• Performs personally and/or ensures client audits and regulatory inspections of the company are managed to facilitate the client/inspector expectations and minimize disruptions to ongoing operations
• Researches the published information, interacts with QA and/or regulatory professionals and maintains knowledge of current expectations, new trends, and proposed changes to regulations that may impact internal stakeholders.
• Leads the evaluation and management of site specific escalations related to persistent or serious misconduct. Participates, as requested, on GCP related projects initiated by internal stakeholders

What you need:  

• An undergraduate degree in health-sciences.
• 5 to 10 years of experience with auditing, compliance, and SOP development preferred.
• Experience leading or direct management of staff is preferred.
• Must have thorough understanding of GLP regulations and bioanalytical guidelines
• Understanding of all aspects of bioanalysis

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.