Director, Clinical Quality Assurance

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information, visit www.abbvie.com.

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. 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

The 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. 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 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 AbbVie quality systems and 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 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; provides clear direction, establishes stretch goals, and communicates expectations clearly.
• Maintains two-way dialogue with others related to work assignments and results. 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.

Qualifications

• 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; motivates and can influence others, including those over whom they have no direct authority.
• Professional, accountable, energetic and collaborative team player.
• Thorough knowledge of quality systems, auditing standards and quality management processes. Advanced business acumen. Extensive knowledge of worldwide regulatory requirements and industry best practices that govern clinical development.
• Ability to work in a fast-paced, high pressure and changing environment autonomously; flexibility to adapt and effectively prioritize.
• Project management, interpersonal, and communication skills with the ability to influence.
• Builds strong teams and relationships with peers and cross-functionally at both global and local levels.
• Excellent communication skills, including superior negotiation and influencing skills; ability to manage difficult conversations and seek alignment; ability to motivate and develop high-performing teams.
• Well-developed leadership competencies including motivation, cultural awareness, active engagement, relationship building, sound judgment, and management of sensitive proprietary information.
• Ability to direct and coach to prioritize and balance multiple tasks simultaneously.
• Extensive knowledge of clinical development for biopharmaceuticals. Bachelor's degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience.
• Bachelor's or Master's degree or equivalent education with typically 12+ years in the function or closely related field. Biopharmaceutical industry experience in quality assurance, compliance and/or related development functions, including 5 years in leadership positions (people and/or initiatives/projects).
• Ability to travel (on average 10-20%), including international travel.

Compensation & Benefits

• The compensation range is the range of possible base pay the Company believes in good faith it will pay for this role at the time of posting based on the job grade. Individual compensation depends on many factors including geographic location.
• Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in short-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html. Applicants seeking a reasonable accommodation: https://www.abbvie.com/join-us/reasonable-accommodations.html