Associate Director, QA

AbbVie•North Chicago, IL

7h•$141,500 - $268,500•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience
7+ years of experience in the pharmaceutical industry in the fields of clinical development, clinical trials regulatory affairs and/or quality assurance supporting those areas, or with a regulatory authority.
Detailed knowledge of quality systems and auditing standards.
Extensive knowledge of worldwide clinical regulatory requirements and industry best practices, quality management principles, including global and regional regulations and internationally recognized standards (e.g. ICH, ISO).
Excellent communication skills, including superior negotiation and influencing skills.
Acute listening skills to gain understanding or to solve a problem and the ability to recognize the difference.
Ability to manage difficult conversations and seek alignment.
Ability to manage complex issues and distil information.
Strong analytical skills and the ability to proactively identify, rapidly assess, and effectively manage business and compliance risks.
Significant experience leading cross-functional and multi-location teams through complex projects with demonstrated flexibility to adapt to changing assignments and ability to effectively prioritize.
Ability to think strategically and communicate effectively with colleagues at all levels, including senior management.
Well-developed leadership competencies to deliver team objectives and projects.
Willingness and ability to perform domestic and international travel

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.
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.