AbbVie Auditor Clinical QA in Maidenhead, United Kingdom
Auditor Clinical QA
United Kingdom, England, Maidenhead
4 additional locations
Germany, Rhinland-Palatinate, LudwigshafenBelgium, Walloon Brabant, WavreNetherlands, North Holland, HoofddorpUnited Kingdom, England
This role can be based in any of AbbVie’s EU affiliate offices.
Team: Working in a stimulating matrix environment, across multiple countries, reporting to the EEMEA, Area Head of RDQA.
Package: Competitive salary and comprehensive benefits package.
AbbVie is an ambitious health business where people and quality of life come first. The experience of illness is personal, so we care about the things that matter to patients. As market leader, we team with partners to co-design health solutions around our innovative medicines for complex diseases, which improve standards of care. Helping people to be fit for work and family life is how we make a remarkable impact to the lives of men, women and children.
Primarily responsible for conducting audits of investigative clinical sites in R&D to assess and assure compliance with regulations, guidelines, policies, procedures and sponsor requirements
Lead audits of investigative clinical sitesto ensure compliance to global regulatory and AbbVie requirements.
Effectivelycommunicate audit results, both orally and in writing. Review corrective actionplans/audit responses for adequacy and approve if adequate
Leads/conducts other audit types, asrequired
Supports regulatory inspections andexternal audits, as required
Provides support and consultation tobusiness partners with regards to GCP compliance issues
Review clinical research documents, such asresearch reports, to assess the quality and compliance to policies, procedures,and applicable governmental regulations, as required;
Initiates/participates in qualityimprovement projects
Bachelor’s degree in a physical science,life science, nursing, pharmacy or equivalent experience required
Demonstrable Industry experience in QualityAssurance or Clinical Research Development is a must.
Experience of supporting / participating inaudits or regulatory inspections
High level of awareness and understandingof clinical trial regulations (e.g. ICH-GCP, EU Clinical Trial Directive)
Excellent planning and organizationalskills
Ability to work effectively and efficientlyin a dynamic environment with minimal supervision
Travel: Yes, 25 % of the Time
Job Type: Experienced