QA Auditors/ QA Manager /QA Director

Rbw Consulting Limited ,
London, Greater London
More Details
Salary: Salary: On application

Overview

Quality Assurance Director Overview My client is an international CRO who has an opportunity for a Director Level Quality Assurance expert who will lead the QA Department and assist in overseeing all global QA processes, functions and employees. The ideal candidate will have 6 years of experience in Quality Assurance with strong knowledge of global GCP regulations and guidelines, including Regulated Inspections, CAPA programs, Audit Management and applications of Part 11 to computerized systems used in Clinical trials. Responsibilities Manage and lead regulatory inspections conducted at company, the Sponsor and/or investigator sites; Provide leadership and management of the QA Department; Oversee internal process/system audits and external investigative site/ vendor audits; Conduct and assist in the development of trainings on a company-wide basis; Actively participate in the CAPA program, quality data analysis/trending and continuous process improvement initiatives; Provide support and leadership in Sponsor audits; Provide QA representation in project meetings, bid defences and Sponsor governance activities Provide internal consulting to project-teams as needed; and Collaborate with external clients and/or Sponsors. Qualifications Bachelor’s degree in Life Sciences; 6 years of experience in a QA department in PHARMA or CRO industry; Expert knowledge of GCP Regulations and Guidelines as well as National Regulations and EU Directives within the EU member states. Team Management Experience Essential Quality Assurance Manager You will manage QA Auditors and be responsible for their training and development. Assist with the planning and maintaining the annual audit schedule with Director, including proposing and developing audit plans for new projects. Responsibilities Independently coordinate all types of audits and ensure completion of QA department responsibilities identified by SOPs Oversee and manage auditor capacity planning and audit reporting requirements Undertake line management responsibilities and development of Audit team Assist Director to conduct internal system audits and external vendor audits for central laboratory and CRO operational functions Participate in audits by Sponsors and/or Regulatory Inspectors Identify areas of risk and provide input on an effective QA oversight plan to mitigate risk; Proactively identify and resolve non-compliance issues Create and revise departmental SOPs and guidelines. Qualifications A Bachelor`s degree, preferably in Life Sciences Previous experience in a QA role, within a CRO or pharmaceutical setting is preferred Ability to manage a risk-based approach to the planning and scheduling of all audits Previous experience overseeing and managing auditor capacity planning and audit reporting Line management experience Demonstrated ability to think strategically; excellent leadership and influencing skills. Salary: On application

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