Senior Auditor, Quality Assurance - CAPA Management (early phase) team

Senior QA Auditor - Homebased - Bulgaria or Poland

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Job Description Summary:

The Senior QA Auditor perform tasks relevant to the assigned Quality & Compliance (Q&C) function including but not limited to conducting internal and vendor audits, External audits/Regulatory Authority Inspections management and CAPA management. S/he will assist with the implementation and maintenance of an effective Quality Management System/Quality Assurance program within the relevant Quality &Compliance team. Will also be expected to perform departmental and ICON staff training regarding ICON's quality system, Q&C tasks & processes, applicable standards, regulations, as well mentoring new or developing Q&C staff as assigned. The incumbent will support with business development activities and Q&C Initiatives as needed.

CAPA MANAGEMENT Responsibilities (97%):   

• Lead investigations, root cause analysis (RCA) and resulting CAPA management for ICON Quality Issues.
• External audits/inspections findings ensuring responses/CAPA are in line with ICON SOPs and submitted within the require timelines.
• Ensure that the ICON’s QMS/tracking system is updated with the appropriate information and documentation.    
• Follow-up of CAPA plans to ensure actions are completed on time and the evidence available are adequate.
• Perform the assessment of the potential Quality Issues to determine whether they meet the requirements of an ICON Quality Issue , document the outcome and record the Quality Issues as requested.
• Determine effectiveness check requirements for responsible CAPA, define the effectiveness check plan, track and complete the effectiveness checks as required, determine the outcome and inform operations and Q&C management accordingly.
• Assist with the review of effectiveness check plans and effectiveness check outcomes for more junior QA auditors.  
• 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.
• Support ICON functions and client for regulatory reporting such as regulatory reporting documentation as needed.
• Ensure that any case types including suspected scientific misconduct, risk cases and potential serious breach is tracked and documented as requested.
• Liaise with clients and regulatory authorities as needed.

EXTERNAL AUDITS/INSPECTIONS MANAGEMENT responsibilities:  

• Management of audit observation responses and corresponding CAPAs.
• Lead the preparation, and host Sponsor audits & Regulatory Inspections of ICON and of Investigational Sites. This may include but it’s not limited to:
- Supporting  ICON and Sponsor operational teams during the audit/inspection
- Liaising with the sponsor as needed
- Reviewing & processing any ICON document requests
- Finalizing and distributing daily summaries
- Attending the audits/inspection on site as needed
- Follow-up activities including provision of outstanding requests
• Lead inspection readiness team activities for projects/programs/assets.
• Support/mentor other Auditors with the tools needed to host independently.

• Travel (up to 35%) domestic and/or international, on occasion and this may increase based on business needs (not more than 2-3 times a year).

What you will have:

•  4-6+ years’ experience working in a clinical, regulatory, pharmacovigilance, or quality environment within CRO/pharmaceutical/healthcare industry.
•  Advanced knowledge of GCP (Good Clinical Practice).
•  Excellent organizational skills.
•  Knowledge of internal auditing standards.
•   Must possess a technical knowledge that is applicable to clinical drug development.
•  An undergraduate degree, its international equivalent in the sciences, technology, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required.
•  Experience in investigator site, vendor, and process audits.
•  Open to occasional travel, if required
•  Excellent knowledge of MS Office (including Microsoft Word, PowerPoint and Excel).
•  Critical thinker that sees the "big picture" (e.g. overall themes, trends, goals), generates innovative ideas and solutions to problems and makes recommendations in the face of complexity, conflicting pressures and ambiguous circumstances.
•  Professional communicator, able to gain and maintain a trusted relationship while delivering difficult messages
•  Team worker, able to listen to others but also influence in order to see the wider picture and achieve a vision
 

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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply