* This role could be based in any of our hub locations (North Chicago, IL/Cambridge, MA/Worcester, MA/Florham, NJ/Irvine, CA/San Francisco, CA) in US
- Leads and develops a team of Clinical Auditors, based in the Americas, in the development and execution of all clinical audit types. Build a strategic, high-performing team that operates cross functionally to build-in quality to AbbVie processes from the outset.
- As part of the Clinical Audit Leadership Team, contributes to the development of the global Clinical Audit strategy while driving this at an Americas level.
- Provides leadership and strategic insight to the risk-based clinical audit program, execute more complex audits and work with auditees to resolve any non-compliance(s) identified.
- Leads and delivers innovative quality strategies and solutions through collaboration with business partners and other GxP RDQA functions to support effective and timely solutions to compliance issues and/or questions.
- Drives development/continuous improvement of necessary quality and clinical systems by leading and/or supporting implementation of initiatives to assure compliance to regulations and corporate policies.
- Analyses and evaluates processes that support clinical development in order to assure quality and compliance.
- Drives for results for self and staff by providing clear direction, establishing stretch goals/assignments and is able to communicate expectations and objectives in a clear and well-planned manner. Maintains two-way dialogue with others related to work assignments and results; brings out the best in people.
- Provides expert advice and support on clinical regulations, guidance and expectations to RDQA and business colleagues.
- Provide strategic input to the inspection support model and actively support GCP inspections onsite or remotely if needed
- Promotes continuous education on quality and clinical guidelines and regulations for self and other AbbVie staff.