Director, Clinical Quality Assurance

Job description

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. 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 design, working knowledge of current and future practices 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 in an autonomous manner. Flexibility to adapt to changing conditions and ability to effectively prioritize. Grasps the “essence” and can change course quickly, where indicated. 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 to drive performance. 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 motivate and develop high-performing teams with challenging goals that bring growth and development. Well-developed leadership competencies include motivation, cultural awareness, active engagement, relationship building, sound judgment, and the management of sensitive proprietary information. Ability to direct and coach to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy internal stakeholders. 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 other related development functions that includes 5 years in leadership positions (people and/or initiatives/projects) Ability to travel (on average 10-20%) including willingness and ability to perform international travel Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. ​ We offer a 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 our short-term incentive programs. ​ Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 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 US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: 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 about AbbVie, please visit us at . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .