* 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

Purpose:

As the Head of the Americas Clinical Quality Audit team, leads a high performing team to deliver on the Clinical Audit strategy and assure the quality and compliance of AbbVie clinical trials and studies in the region.

• Assures quality and compliance in a regulated environment including AbbVie policies and procedures, country specific requirements, and other applicable standards and worldwide regulations.
• Contributes to the strategic direction of the Clinical Audit Team, ensuring alignment with RDQA policies and procedures.
• Advances the AbbVie Quality System through robust collaboration with business partners and other GxP RDQA functions and implementation of systems and processes required to support global quality assurance requirements.
• Builds and leads high performing teams by creating an inclusive environment, focusing on people development, setting clear expectations, engages team members with clear vision on strategy and implementation. Accountable to employees to coach for success in performance.

Responsibilities

• 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.