Senior QA Auditor

Job Title: Senior QA Auditor

Location: Ireland, Dublin

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:

Working in the Compliance team leading and overseeing quality issues and CAPAs globally across multiple ICON functions. This includes leading teams through root cause analysis and CAPA development, liaising with internal and external customers and performing effectiveness checks. The role may also participation in audits and regulatory inspections of ICON and ICON investigator sites.

General Responsibilities:

• Perform tasks relevant to the assigned Quality & Compliance function including but not limited to conducting leading Regulatory/Sponsor inspection/audit defense, quality Issue and CAPA management and conduct of effectiveness checks
• 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.

AUDIT DEFENSE Responsibilities:

Lead Sponsor Audits and/or Regulatory Inspections of ICON activities including;

• Preparation activities including liaising with the client, identifying, escalating and mitigating any risks and preparing operational teams
• Host Sponsor on-site or remote audits including leading opening and close out meeting activities, supporting operational targets in audit defense activities, escalating potential issues as needed, and providing audit summaries to senior management.
• For regulatory inspections of ICON, lead / assist with the leadership of the on-site inspection activities: lead document request activities and/or act as 'back room' leader, lead inspection room activities on behalf of the Q&C Manager / Director, when needed, including direct communication with the inspectors.
• Follow-up activities including provision of outstanding requests, handover to the CAPA Lead.
• Review and provide input/feedback on external audit summaries generated by other team members
• Lead Regulatory Authority Site Inspections support activities including:
• Preparation activities such as liaising with the client: identifying, escalating and mitigating any risks; preparing operational teams and investigational site staff, as needed.
• Support operations during the inspection conduct, such as review of any document requests, liaising with the client and attending the inspection on site as needed
• Follow-up activities, such as liaising with the client and/or regulatory inspectors, finalizing and distributing daily summaries and handover activities to the assigned CAPA Lead.
• Follow-up activities, such as liaising with the client and/or regulatory inspectors, finalizing and distributing daily summaries and handover activities to the assigned CAPA Lead.

CAPA MANAGEMENT Responsibilities:

• Lead Quality Issues investigations, root cause analysis (RCA) and resulting CAPAs management, including;
• Lead RCA and investigation meetings with relevant operational responsible persons,
• Liaise with the client, providing input on CAPA plans and
• Ensure ICON's QMS/ tracking system updated with the appropriate information and documentation
• Lead CAPA management for internal & external audits & inspections including:
• RCA and investigation meetings with relevant operational responsible persons,
• Liaise with the client and/or regulatory inspector, providing input on CAPA plans and
• Ensure ICON's QMS/ tracking system updated with the appropriate information and documentation
• Assist with the tracking of incoming QIs and QI triage and assessment process.
• Determine effectiveness check requirements for responsible CAPAs, track and complete effectiveness checks as required.
• Assist with the review of effectiveness check requirements, effectiveness check plans and effectiveness check outcomes
• Assist Q&C Management / Director with oversight of open CAPAs, trending and analysis of CAPAs and metrics reporting. This includes providing summary information/input to Governance reports.

What you will need:

• University/Bachelors Degree (Life Sciences)

• Experience in Pharmaceutical and/or GXP environment including in-depth knowledge and experience in Quality Assurance auditing and/or with relevant regulatory compliance /Quality System , including quality system development and leading system development projects.
• A minimum of 3 years' experience in Pharmaceutical and/or GxP environment and Quality Assurance auditing
• Thorough knowledge of relevant GxP regulations and accreditation requirements as relevant, including but not limited to GCP, GMP, GDP , GVP, GLP, 21CRF Part 11, CAP, CLIA and any local regulations as applicable to the business
• Ability to review and evaluate clinical data/records/systems/processes
• Thorough knowledge of the clinical development process
• Thorough knowledge and experience in performing and leading Root Cause Analysis.
• Ability to manage complex issues and related CAPAs, including leading large cross functional teams, task prioritization, and project management as needed.
• Demonstrated coaching, mentoring & training skills, including the ability to give constructive feedback
• Ability to work as part of a team
• Highly developed problem solving skills, and the ability to resolve difficult situations.
• Well-developed interpersonal and communication skills (oral and written) with prior experience conducting presentations or facilitating meetings.

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.

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