Senior Manager, RDQA AREA

Company Description

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In, and Tik Tok.

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 Abb Vie 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 Abb Vie 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 Abb Vie 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.

Bachelor's degree required preferably in Biology, Nursing, Pharmacy, or other medical science degree combined with equivalent technical experience. 8+ years of biopharmaceutical / medical device industry experience in quality assurance, compliance, regulatory affairs, clinical research and/or other related development functions that includes 3 years in leadership positions (people and/or initiatives/projects).

Strong understanding of local and global regulatory and legal requirements and of the approach and perspectives of regulatory agencies. Ability to ensure…