Senior Auditor, 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.

Senior Quality Assurance Auditor Roles and Responsibilities:

Senior Quality Assurance Auditor  independently conducts the following activities as assigned by QA management:

• Performs contracted, routine and complex audits according to client expectations and/or PRA SOPs
• Often assigned to lead a team of auditors and/or conduct complex audits independently
• Plans and ensures audits are scheduled
• Conducts audits to identify non-conformities in adherence to protocols, SOPs, regulations, GCP, and expectations for data accuracy and completeness
• Reports observations/findings according to client or PRA SOPs and report templates.
• Tracks, collects and reports responses and corrective actions per contract with client or PRA SOPs.
• Documents closure of audit and interprets regulations and guidance documents governing GxP and applies the interpretation for PRAHS staff.
• Researches the published information, interacts with other QA/regulatory professionals and maintains knowledge of current expectations and new trends and proposed changes to regulations.
• Shares questions and issues posed to QA with global PRA QA staff as necessary to insure best advice is obtained.
• Compiles response from QA staff and literature and replies to customer and more broadly throughout PRAHS as needed.
• Facilitates client audits and regulatory inspections of PRA to ensure that client auditors and inspectors receive access to needed documentation and staff with minimal disruption of ongoing operations.
• Assigned to participate in QA projects such as management of issue escalations, CAPA projects, or other QA initiatives
• Knowledge of GxP,regulatoryrequirements which impact company policies, directives, and procedures
• Good knowledge of the drug development processes, regulation awareness and scientific terminology
• Good knowledge of SOPs and related documentation in a regulated industry
• Proficiency in operating computers applications and navigating the internet
• Excellent organizational skills, be logical, systematic and curious; must be able to gather and interpret relevant information; ability to work in a high volume and strict deadline environment
• Ability to work in ahigh volume and strict deadline environment
• A thorough understanding of drug, biologics and device clinical trial development processes
• Assist with the implementation of the audit programs Act as project-specific liaison and provide input for audit plans
• Must have experience presenting conclusions in a clear and concise manner
• Independently manage regulatory agency inspections or client audits in the areas of GxP
• Performs as a lead or part of a team investigating reported non-compliance
• Work is consistently of high quality
• Develops solutions independently
• Provides guidance to less senior staff and independently resolves issues and problems
• Assist Manager with departmental activities, when applicable.
• An undergraduate degree, its international equivalent in health sciences, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required
• Read, write and speak fluent English; fluent in host country language required.5+ years’ experience working the clinical, regulatory, or quality environment within CRO/ pharmaceutical /healthcare environment
• Excellent verbal and written communication skills, interpersonal skills
• Excellent organizational skills
• Must possess a technical knowledge that is applicable to clinical drug development and possess the expected ability to master the needed understanding of clinical and technical areas.
• Experience working within a clinical research organization
• Experience in Quality Assurance function is strongly preferred
• Clinical site monitoring, GxP quality assurance auditing, and GxP regulations
• Computer Systems Validation(CSV) experience
• Process improvement experience.
• #LI-MO1

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.