Hiring: Director, Clinical Quality Assurance Company: AbbVie Location: North Chicago, IL Job Posted Time: 2026-09-03 11:05:32 Target Skills & Keywords : Change Management, GCP, Project Management, Quality Assurance, R, Regulatory Compliance, Risk Management About the job Experience: •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) Required Skills: •This role could be based in AbbVie's Lake County, IL/Irvine, CA/ EU/UK •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. •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. Qualifications: •Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner. •Demonstrated capacity 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. •Demonstrated capacity 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. •Well-developed leadership competencies include motivation, cultural awareness, active engagement, relationship building, sound judgment, and the management of sensitive proprietary information. •Demonstrated capacity to direct and coach to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy internal stakeholders. Compensation: •$182,000 - $346,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!