Summary:

As an independent RDQA Organization, our commitment is to drive quality excellence as a strategic advantage across all stages of discovery and development for the lifecycle of the product to achieve product realization and to accelerate access to innovative therapies for our patients. AbbVie’s R&D global trial footprint has been expanding due to growth in the pipeline and the complexity of global development resulting in an overall increase in global trials in the Affiliates. In addition, the acquisition of Allergan and integration with AbbVie have significantly increased clinical trials managed from the Affiliates. RDQA AREA focuses on proactive quality and quality output in support of clinical development/R&D enterprise within designated countries around the world.
AREA supports countries in Europe, Americas and Intercontinental as defined by AbbVie.

The expected results in the Affiliates are as follows; quality excellence, realization of R&D goals and objectives for submission of new therapies including but not limited to adherence to One AbbVie Quality System, execution of RDQA Quality System Excellence (CAPA, Change Management, Quality Risk Management, Documentation Standards) and the assurance of integrity data. Scope includes R&D and clinical research activities conducted by Affiliates or AbbVie within the region, to achieve first pass approvals thereby advancing the pipeline.

This position will report to RDQA Associate Director or RDQA Global Director, AREA.

Responsabilities: 

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