Clinical Quality Assurance Auditor (26401)

Recruiter
BTG
Location
Frimley, UK
Salary
Competitive
Posted
18 Jul 2019
Closes
22 Jul 2019
Ref
1212473506
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Requisition ID 26401 - Posted 07/16/2019 - 526 COGs - Quality Affairs - General (COGs) (526) - Quality - Employee - Full Time (EMP_FT) - Position Location (1)Imagine where we can go.Current OpportunityBTG is a growing international specialist healthcare company. Our mission is to bring to market medical products that meet the needs of specialist healthcare physicians and their patients. We have an exciting opportunity for a:Broad FunctionConduct 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 BTGs 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 staffResponsibilitiesConduct internal GCP audits of Clinical Development systems and processes including Biometrics.Conduct external GCP audits of vendors, investigational sites and CRO to ensure that BTG 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 BTG 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 inspectionsAdvise Clinical Development on the implementation of effective, compliant, standardized processes and systems (QMS) that enable BTGs clinical investigation-studies to be performed in compliance with relevant country Good Clinical Practice (GCP) RegulationsDraft 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 BTG valuesThe above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.Principal relationshipsAccountable to - Clinical Quality Assurance ManagerInternal - Clinical Development, Biometrics, Clinical, Quality, Regulatory Affairs, Finance, Legal and Compliance departmentsExternal - Government Healthcare Agencies, Vendors, CROs and Investigational sitesEducation and experienceBS 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).Skills and attributesExcellent 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).BTG is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values:Openness ▌Accountability ▌Teamwork ▌Integrity ▌Delivery ▌Continuous Learning

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