Governance Risk & Compliance QA Auditor I

Are you ready to be a part of a fast growing winning team? ICON’s award-winning study execution capabilities have led to the approval of 18 of the world’s top 20 best-selling drugs. Make your experience count for the benefit of patients worldwide.

Governance Risk & Compliance QA Auditor I

China

ICON Governance Risk and compliance(GRC) are responsible for management of sponsor audits and inspectors of ICON. You will be responsible for operations with completion of resulting CAPAs and management of quality issues. In addition you will be supporting Clinical QA Team for management of sponsor audits and inspections in the APAC region. 

Responsibilities

[AUDIT DEFENSE Responsibilities ]

• Assist with the preparation, conduct and follow up of Sponsor audits and Regulatory inspections of

ICON including;

- Host Sponsor or  Regulatory onsite or remote  audits/inspections such  as  leading/co-leading opening and close out meeting activities, processing document & information requests, supporting operational  targets  in  audit  defense  activities,  leading audit/inspection  support activities/ preparation work streams, escalating potential issues,  and providing audit summaries to senior management, as needed

- Follow-up activities including provision of outstanding requests, handover to the CAPA Lead.  

• Assist with the preparation, conduct and follow up of Sponsor audits and Regulatory inspections of

Investigational Sites including:

- Preparation activities such as liaising with the Sponsor; identifying, escalating and mitigating any risks with the appropriate ICON management; preparing operational teams and investigational site staff, as needed

- Support ICON and Sponsor operational teams during the audit/inspection conduct including review & processing any ICON document requests; liaising with the Sponsor under guidance of his/her line manager; finalizing and distributing daily summaries and attending the inspection on site as needed

- Follow-up  activities,  including  liaising  with  the  Sponsor  and/or  regulatory inspectors  (under guidance of his/her line managers) and handover activities to the assigned CAPA Lead. 

[CAPA MANAGEMENT ] 

•Lead Quality Issues investigations, root cause analysis (RCA) and resulting CAPA 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 anddocumentation

•Lead CAPA management for internal & external audits & inspections including:

- RCA and investigation meetings with relevant operational responsible persons,

- Liaise with the Sponsor and/or Regulator

- Provide input on CAPA plans

- 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 CAPA, track and completeeffectiveness checks as required

• Assist  with  the  review  of  effectiveness  check  requirements,  effectiveness  check plans  and effectiveness check outcomes

To be successful, you will have;

• More than 3 year experience in the clinical research filed, working as a CRA, Study Start-up Associate, Project Manager, etc.

• A bachelor’s degree in a science or medical area. Ideally you’ll have a master’s degree that focuses on clinical research;

• The ability to communicate well, an understanding of compliance as well as the confidence to obtain funding;

• Good command of written and spoken English;

• Computer-literacy;

Why join us?

On-going development is vital to us, and as a member of our team you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. We offer a very competitive salary and benefits package that includes an excellent retirement plan, health coverage, paid time off, income protection insurance programs, and staff recognition schemes.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin.

If you would like more information please visit our company website: www.iconplc.com  or https://careers.iconplc.com or feel free to email me directly: Jennifer.kim@iconplc.com