QA Auditor II

Governance Risk & Compliance QA Auditor - less travel, some domestic travel may be required for training and/or inspection management

Beijing, China / Taipei, Taiwan

ICON Governance Risk and compliance (GRC) are responsible for management of sponsor audits and regulatory authority inspectors of ICON. Responsibilities include supporting preparation activities and management of sponsor audits and inspections in the APAC region, including completion of resulting CAPAs and management of quality issues.

[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 and liaising the clients.

* 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 management of resulting CAPAs.

[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 and documentation

*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 complete effectiveness 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.

* Previous experience in quality and compliance management to meet GCP requirements and/or experience with regulatory authority inspections is a plus

* 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.