Auditor, RDQA Clinical Quality Audit

Primarily responsible for the execution of the Clinical audit program, including scheduling, planning, reporting and resolution of Clinical audits. Ensuring alignment with RDQA policies and procedures wherever possible and contributing to the development and implementation of the Clinical QA quality system. Provision of advice and support on GCP and quality topics to business partners to ensure compliance with worldwide requirements and expectations.
Responsibilities:
Assure quality and compliance in a regulated environment that includes worldwide regulations, country specific and other applicable standards and AbbVie policies and procedures by continuous evaluation of Clinical processes through audit and QA oversight activities.
Lead and participate in Clinical Audit scheduling, planning and conduct activities to assess compliance with regulations, guidelines, AbbVie policies and procedures and sponsor requirements. Clinical audit types include investigator clinical site, process, system and Affiliate audits.
Effectively communicate audit results, both orally and in writing, within target timeframes.
Review and approve Corrective Action Plans submitted in response to audit observations within target timeframes and tracking of actions to completion.
Advance the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance requirements. Supports maintenance or development of Quality standards relating to Clinical audit.
Contribute to continuous improvement initiatives/projects to help assure compliance to regulations and corporate policies.
Participate in and support GCP inspections, as required.
Provide support and consultation to RDQA and business partners with regards to GCP regulations.
Promote continuous education on quality and clinical guidelines and regulations for self and other AbbVie staff.
Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience
3-5 years of experience in the biopharmaceutical industry or with a regulatory authority
3-5 years of experience in Quality Assurance and/or Clinical Research Development
Strong analytical skills and the ability to draw conclusions from presented data
Ability to work effectively and efficiently in a dynamic environment with minimal supervision
High level of awareness and understanding of clinical trial regulations (e.g. ICH-GCP, EU Clinical Trial Directive/Regulation) and industry best practices
Flexibility to adapt to changing assignments and ability to effectively prioritize
Good project management, interpersonal, and communication skills with ability to work independently and as part of a team
Willingness and ability to perform international travel

Employment type
Full-time

Work arrangement
Yes