A leading international healthcare company have a new opportunity for an experienced Clinical Quality Assurance Auditor to join its Surrey site. Your role will be to conduct internal and external GCP audits. This will involve approximately 30-40% travel although this will be as and when, as opposed to set time away within each month. You will also play a key part in developing strategy across the QA and clinical departments. You must have proven experience in clinical quality assurance.
Conduct internal and external GCP audits. Facilitate closure of audit findings, assist with root cause analysis (RCA) and action plan development and drive corrective actions to completion. Advise Clinical Development on the implementation of effective, compliant, standardized processes and systems (QMS) that enable company clinical investigation-studies to be performed in compliance with relevant country Good Clinical Practice (GCP) Regulations. Assist in developing and conducting GCP training for in-house and clinical investigational staff
* Conduct internal GCP audits of Clinical Development systems and processes including Biometrics.
* Conduct external GCP audits of vendors, investigational sites and CRO to ensure that studies are being performed and documented in accordance with the principles of GCP. Coordinate and analyse audits conducted by third parties.
* Facilitate closure of audit findings, assist with root cause analysis (RCA) and action plan development, drive corrective actions to completion and conduct effectiveness checks. Maintain tracker, implement and present metrics.
* Maintain the Global Clinical Quality Assurance (CQA) Audit Schedule, track progress, implement and present metrics.
* Provide guidance and direction to company Development and Clinical staff on pertinent GCP standards to enable development of SOPs and compliant systems that fulfil GCP requirements for International and local Regulatory Agencies as well as ethics committees.
* Assist with the development and conduct of GCP training for in-house and clinical investigational staff.
* Assist with the coordination and implementation of inspection readiness activities.
* Assist with hosting Regulatory Authority inspections
* Advise Clinical Development on the implementation of effective, compliant, standardized processes and systems (QMS) that enable clinical investigation-studies to be performed in compliance with relevant country Good Clinical Practice (GCP) Regulations
* Draft inspection readiness plan and coordinate implementation of inspection readiness activities.
* Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with company values
Education and experience
* BS or equivalent in Pharmacy, Nursing, Biology, Pharmacology or allied health science subject. Higher level degree is preferred.
* Experience in clinical quality assurance or equivalent. Experience in a CRO or a research based healthcare company. Experience in a leadership or training role would be an advantage.
* A sound understanding of Good Clinical Practices as interpreted by the global regulatory authorities.
* At least two years of GCP auditing experience both internal and external (vendors and investigational sites).
* Excellent written and verbal communication skills. Ability to communicate assertively with tact and diplomacy.
* Strong leadership, project management and organisational skills.
* A team player who can work well with peers and senior medical personnel and deliver pragmatic but sound quality solutions to identified issues.
* Willing and able to travel to conduct global audits and meetings (up to 40 % travel)
You must be eligible to work in the UK. Learn more
- Agency: Cranleigh Scientific
- Reference: BBBH5402
- Posted: 27th June 2018
- Expires: 25th July 2018