Purpose:
AbbVie 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 AbbVie’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.
The Director, Clinical Quality Assurance is responsible for developing and implementing global strategic quality oversight for Therapeutic Areas (TAs) within clinical development programs. This role ensures that R&D complies with corporate policies and worldwide regulations. This position provides strategic leadership, ensuring inspection readiness and delivering comprehensive QA perspectives for assigned TAs. It involves influencing decision-making processes to embed quality requirements within improvement initiatives. With a focus on pro-active quality this role supports Clinical Development globally to ensure; quality excellence, data integrity, the realization of R&D goals and objectives for submission of new therapies, adherence to the AbbVie Quality System and execution of RDQA Quality System Excellence (CAPA, Change Management, Quality Risk Management, Documentation Standards). Scope includes R&D and clinical research activities for the R&D pipeline to achieve first pass approvals thereby advancing the pipeline. The position will report to Senior Director, Clinical Quality Assurance.
This role could be based in AbbVie's Lake County, IL/Irvine, CA/ EU/UK
Responsibilities:
Director, Clinical Quality Assurance will provide strategy and direction for quality in clinical trials. Clinical Quality Assurance Managers, Sr. Managers and Associate Directors will report to this role. The following are key responsibilities:
- Delivers innovative quality strategies and solutions through collaboration within RDQA and R&D personnel, all levels of AbbVie management, other GxP functions, and external service providers to support effective and timely solutions/responses to compliance issues/questions.
- Build 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.
- Connection to Vendor QA and AREA QA upholding the core principles of GCP across the matrix of QA teams supporting development. Engage across QA GxPs and deliver mitigation strategies to critical business partner networks.
- Develop a sustainable, collaborative relationship with clinical development leaders and organizations to ensure, promote, and guide that AbbVie quality systems, quality objectives, are understood and maintained to achieve AbbVie, 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 can 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. 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 AbbVie staff.