Senior QA Auditor – Client Audit Management

Senior QA Auditor - Client Audit Management 

12 month Fixed Term Contract

Location options:

Dublin (Office based) or

European Regional base locations (Office based, or Remote options available depending on location)

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The opportunity:

The Audit Defense team are seeking an individual to join them on a Secondment basis to cover maternity leave within a Senior Auditor position.  This is a great opportunity for someone with a clinical background to develop their career within Quality Assurance.

This is a specialized team responsible for leading client audits of ICON globally for our clinical, PV and technology services.

The team work directly with the client auditors to arrange, prepare for and host the external audit, liaising with the internal ICON team to ensure the client audit expectations are met and that the audit is a success. The team also manage any resulting observations and CAPAs which ensures the external auditor has one central point of contact for the duration of the audit through to closure.

The Audit Defense team have many years’ experience of hosting both on-site audits conducted at ICON facility, as well as hosting remote audits using technology available to ensure the audit scope can still be met remotely.

Key responsibilities will include:

• Leading and supporting external audits of ICON including scheduling, preparation and hosting.

• Leading CAPA management for external audits of ICON and/or investigator sites, where needed, in order to assure responses are compliant with ICON or Sponsor SOP requirements

• Leading CAPA management for sponsor audits of ICON, including liaising with ICON operation teams to ensure timely completion of audit responses, supporting operations to ensure responses are appropriate, including ensuring appropriate corrective and preventative actions are implemented and liaising with the client to deliver responses with in the agreed timelines and respond to any resulting follow-up.  

• Leading quality issue investigations, including ensuring appropriate root cause analysis is performed, and adequate corrective and preventative actions are implemented.

• Ensuring CAPAs are formally recorded and reported and actions are documented and followed until resolution.

• Identify and track required effectiveness checks and ensure checks are completed within the required timelines.

• Providing advice and support to the operation teams where needed to ensure CAPA are compliant with GCP and applicable regulatory requirements.

• Supporting other Q&C teams with audits of ICON, including conducting audits of ICON, investigator sites and/or vendors, when deemed necessary.

To be successful in the role, you will have:

• Knowledge/ experience in hosting external audits and/or regulatory inspections

• Knowledge / experience in CAPA management, including performing effective root cause analysis

• Ability to review and evaluate clinical data / records.

• Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients.

• Detailed understanding of drug development and clinical trial process.

• Good problem resolution skills.

• Good planning and organizational skills with the ability to multi-task and prioritize effectively.

• Ability to work efficiently and independently under pressure.

• Ability and willingness to travel on occasion to accommodate the client.

• Experience of GCP Guidelines and relevant regulations for the conduct of clinical trials would be beneficial.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.  In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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.

#LI-Remote