Senior QA Auditor

Senior Quality Assurance Auditor

Location: U.S. (remote)

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 organizations.

With our patients at the center 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:

GENERAL Responsibilities

• Perform tasks relevant to the assigned Quality & Compliance function including but not limited to conducting internal and vendor audits, Regulatory/Sponsor inspection/audit defense, case management and CAPA management.
• Conduct departmental and ICON staff training regarding ICON's quality system, Q&C tasks & processes, applicable standards, regulations; mentor new or developing Q&C staff as assigned, including providing constructive and effective feedback to trainees regarding skill capabilities during training.
• Escalate quality and compliance issues to Q&C Line Management and relevant ICON functions as appropriate.
• Delegate assignments to local Q&C audit staff at the request of Q&C management; provides support and escalates for intervention to ensure staff have the necessary tools to perform requested assignments.
• Liaise with clients and operational persons including managers on quality aspects which may include attendance at meetings, oral presentations and audits.
• Assist with business development activities, including the preparation of contracted audit cost proposals/contracts, and attend marketing presentation, when appropriate.
• Have a thorough knowledge of all relevant SOPs, and appropriate regulations and guidelines.
• Understand key business drivers; uses this understanding to accomplish own work.
• Build knowledge of the company, processes and customers.
• Assume additional responsibilities, which are directed by the Q&C Manager or higher.
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (up to 35%) domestic and/or international, on occasion this may increase based on business needs. Depending on Q&C function, an Auditor may be requested to complete all/some of the responsibilities listed below under each heading as needed.

AUDITING Responsibilities:

• Plan and conduct regular internal audits as well as contract audits (including standalone work) and for cause audits of the ICON quality system in order to evaluate the quality system against the requirements appropriate regulations and applicable guidelines.
• Perform the role of a lead auditor to assess the effectiveness of the quality system and to verify that the quality system is being implemented. Assist with the development of the project audit schedule.
• Perform vendor and sub-contractor audits and follow up of previous findings, as well as validation reviews as required.
• Review audit replies to Q&C. Follow up all outstanding replies and report issues to the relevant management for action. Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented. Verification of audit CAPA completion where required by procedure.
• Train QA auditors, and provide a standard for auditing to inexperienced or less experienced colleagues.
• Carry out a senior role in the regional QA department (Project Audits), such as scheduling of audits.
• Operates under moderate supervision and direction and makes decisions frequently that have a direct impact upon the local external and internal audit schedule and the resource allocation for audits within the local department.

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.