Senior Auditor, QA

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 Role: Senior Auditor, Quality and Compliance

Location: Remote (Must be commutable to North Wales, PA)

To be successful in the role, you will have:

Job Title: Senior Auditor, Quality and Compliance

Location: Remote (Must be commutable to North Wales, PA)

At ICON, our people set us apart.

As a global provider of drug development solutions, our work is serious business. However, that does not mean you cannot have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them?

At ICON, we have an incredible opportunity for an expert Quality and Compliance Senior Auditor to join the team in the US.

The Role:

• To lead/support external audits and inspections of ICON including scheduling, preparation and hosting.
• To Lead / Support inspection readiness activities, including inspections of ICON and/or investigator sites.
• To Lead / support CAPA management for external audits of ICON and regulatory inspections of ICON and/or investigator sites, where needed, in order to assure responses are compliant with ICON or Sponsor SOP requirements, Good Clinical Practice guidelines and relevant regulations, including ensuring appropriate corrective and preventative actions are put in place and CAPAs are followed until resolution.
• To Lead / Support Quality Issues (non-conformance / potential NC and complaints), including ensuring appropriate root cause analysis, implementation of corrective and preventative actions and follow-up and effectiveness of resulting CAPAs.
• Lead / Support inspection readiness activities, including inspections of ICON and/or investigator sites.
• Lead CAPA management for inspection of ICON and /or investigator sites, where needed, including ensuring any Inspection CAPA commitments are tracked and followed until resolution.
• Lead 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.
• Lead / support quality issue investigations, including ensuring appropriate root cause analysis is performed, and adequate corrective and preventative actions are implemented.
• Ensure that CAPAs are formally recorded and reported and that corrective/preventive actions are documented and followed until resolution.
• Identify and track required effectiveness checks and ensure effectiveness checks are completed within the require timelines.
• Provide advice and support to the operation teams where needed to ensure CAPA are compliant with GCP and applicable regulatory requirements.
• Lead / support critical CAPA initiatives, as needed
• Support / lead effectiveness check audits, as needed
• Support other Q&C teams with audits of ICON, including conducting audits of ICON, investigator sites and/or vendors, when deemed necessary.
• Travel (approximately 35%) domestic and/or international

What you will need:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• BS degree in Science or other related disciplines
• The requirements listed below are representative of the knowledge, skill, and/or ability required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Background in medicine, science and/or other relevant discipline and appropriate experience.
• Thorough knowledge of GCP Guidelines and relevant regulations for the conduct of clinical trials.
• Knowledge/ experience in hosting external audits and/or regulatory inspections
• Knowledge / experience in CAPA management, including performing effective root cause analysis
• Knowledge / experience in regulatory authority inspections an advantage
• Knowledge / experience in medical Device (MDDR) an advantage
• 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 at least 35% of the time (international and domestic).

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.