Director, Clinical Quality Assurance

Job Description

Abb Vie is dedicated to delivering a consistent stream of innovative, safe, and effective medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research & development, R&D Quality Assurance (RDQA) is committed to driving quality excellence across all stages of discovery and development for the product’s lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients.

Patient needs, stakeholder demands, industry innovation, regulatory landscape, and Abb Vie’s evolved business strategy are complex, rapid pace, and dynamic. Emphasizing and embedding quality in the execution of clinical trials ensures data integrity, fosters regulatory compliance, and contributes to the overall success of drug/device development programs.

This role could be based in Abb Vie's Lake County, IL;
Irvine, CA; EU; or UK.

• Delivers innovative quality strategies and solutions through collaboration within RDQA and R&D personnel, all levels of Abb Vie management, other GxP functions, and external service providers to support effective and timely solutions/responses to compliance issues/questions.
• Builds a strategic, high‑performing team within the TAs that can leverage their comprehensive understanding of the TA, programs, and upcoming development milestones to build quality into our development programs early, prevent risks from impacting submissions and approvals, while increasing success during GCP inspections.
• Maintains connection to Vendor QA and AREA QA upholding the core principles of GCP across the matrix of QA teams supporting development, engaging across QA GxPs and delivering mitigation strategies to critical business partner networks.
• Develops a sustainable, collaborative relationship with clinical development leaders and organizations to ensure, promote, and guide that Abb Vie quality systems, quality objectives, are understood and maintained to achieve Abb Vie, R&D and RDQA goals.
• Drives development/continuous improvement and implementation of necessary GCP systems by leading and/or collaborating on implementation of cross‑functional initiatives to assure compliance to regulations and corporate policies.
• Analyzes and evaluates processes that support clinical development to assure quality and compliance. Leads and develops a team of Program Managers per assigned therapeutic areas in the development and execution of comprehensive quality assurance plans, performance, and Ways We Work Drives for results for self and staff by providing clear direction, establishing stretch goals/assignments and communicating expectations and objectives in a clear and well‑planned manner.
• Maintains a two‑way dialogue with others related to work assignments and results, bringing out the best in people. Performs strategic planning to ensure resources are available for essential quality assurance activities.
• Provides leadership/collaboration in health authority inspections to assure success and supports resolution of findings by working with development business partners.
• Provides expert consultation and direction on complex quality assurance and GCP compliance inquiries from supported organizations.
• Promotes continuous education on quality assurance and GCP guidelines and regulations for self/direct reports and other Abb Vie staff.

• Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner.
• Ability to work at an experienced level, demonstrating effective leadership in interactions with business partners at all levels.
• Steps up and takes leadership to own toughest challenges, persisting to achieve the right results for the organization. Motivates and can influence others, including those over whom they have no direct authority.
• Professional, accountable, energetic and collaborative team player. Ability to advance relationships within function and business partners.
• Thorough knowledge of quality systems, auditing standards and quality management processes. Advanced business acumen, understands complexities of organizational…