Job Description
*Senior Internal Auditor, Quality and Compliance *
*Location:* Remote UK or Ireland
At ICON, it's our people that set us apart.
As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't 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 a we have an incredible opportunity for a *Senior QA Auditor *to join the team. This role can be based out of the UK or Dublin. If UK based there will be an expectation of travel to the Dublin office.
*The Role*
As a *Senior Auditor within Quality and Compliance* and reporting to a senior manager within the team, you will be responsible for performing tasks relevant to the assigned Quality & Compliance (Q&C) function including but not limited to conducting internal and vendor audits, Regulatory/Sponsor inspection/audit defence, case management and CAPA management.
There is travel of up to 35% involved with this role.
* To lead and support external audits and inspections of ICON including scheduling, preparation and hosting.
* To Lead and support inspection readiness activities, including inspections of ICON and/or investigator sites.
* To Lead and 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.
* Identifying and tracking required effectiveness checks and ensure effectiveness checks are completed within the require timelines.
* Providing advice and support to the operation teams where needed to ensure CAPA are compliant with GCP and applicable regulatory requirements.
* Support other Q&C teams with audits of ICON, including conducting audits of ICON, investigator sites and/or vendors, when deemed necessary.
*What you need*
* 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
* 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.
* Good problem resolution skills.
* Good planning and organizational skills with the ability to multi-task and prioritize effectively.
* 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.
* Ability to review and evaluate clinical data/records/systems/processes and make improvement recommendations.
* 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.
* A super team player who is happy to support junior members of the team
* Excellent communication and relationship building skills
*Why join us?*
Other than working with an outstanding team of ambitious people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
Ongoing development is vital to us, and as a *Senior Auditor, Quality and Compliance*, you will have the opportunity to progress your career, with the potential to move into other related areas to improve your skillset. Our benefits package is competitive, our scope is international and we sincerely care about our people and their success.
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