The RDQA AREA Senior Manager will provide support for the assigned countries and region and will
be responsible for the implementation/execution of activities related to proactive quality
management. The following are key responsibilities:
 Maintain a close, collaborative relationship with RDQA functions impacting clinical research
within designated Affiliates in the assigned countries and region.
 Establish collaborative-working relationship with clinical development leaders and staff within
designated Affiliates to advance the AbbVie Quality System, drive quality excellence, and
achieve first pass approval for market authorization by health authorities.
 Oversee quality and compliance in a regulated environment including AbbVie policies and
procedures and country and regional standards and regulations.
 Lead and/or collaborate on development of risk identification and risk mitigation or control
strategies for clinical research activities including clinical trials within designated countries with
periodic reviews of quality and compliance data for the purposes of continuous improvement.
 Establish quality measures with the desire to achieve RDQA quality goals. Drive quality strategy
in designated countries and region in conjunction with other RDQA AREA personnel.
 Manage governance/oversight that is “fit for purpose” and in relation to the One AbbVie
Quality System. Identify trends, root causes, and potential risks to mitigate and/or prevent
issues that impact clinical research. Drive vision of continuous state of regulatory
preparedness.
 Ensure consistent understanding of the quality requirements for clinical research activities
within Affiliates, works closely with Affiliates R&D Management on health of Quality System,
identifies issues of quality and compliance that will impact overall goals and desired outcomes.
 Maintain awareness of all applicable regulations and develop appropriate standards to measure
quality in assigned countries and region relating to clinical research.
 Support necessary supplier visits, audits and vendor qualifications
 Develop inspection strategy in collaboration with AREA Associate Director and relevant
functions and provide inspection-readiness support for all local / regional Health Authority
inspections.
 Provide oversight, support and follow-up (inspection report response) for local Health Authority
inspections with employees and management in assigned countries and region. Participate in
Health Authority inspections as needed.
 Determine need for country/process assessments/audits in collaboration with Clinical Audit and
Clinical PM.
 Conduct audits as required to assess compliance with regulations, guidelines, policies and
procedures and Sponsor requirements. Effectively communicate audit results, both orally and
in writing. Review and approve corrective action plans/audit responses.
 Support the development of robust audit and inspection responses through coaching and
education.
 Mentor AREA Managers/AREA Associates or line management as additional Lead responsibility