Senior Manager, Clinical Quality Assurance

About AbbVie 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. It impacts people’s lives across immunology, oncology, neuroscience, and the Allergan Aesthetics portfolio. Purpose Lead the management of GCP quality activities for clinical studies and projects, ensuring proactive quality management, compliance with corporate policies, functional procedures, and global regulations. Act as the primary GCP quality interface across R&D, influencing quality processes and supporting the submission‑ready data of therapies. Responsibilities Develop and manage project timelines and deliverables for the RDQA Comprehensive Quality Strategy plan, including leadership in risk and issue management. Assess the effectiveness of the quality system and ensure inspection readiness by designing an audit program of internal and external compliance audits and applicable assessments. Interpret, explain, and apply current governmental regulations, guidelines, policies, and procedures to study protocols and related activities. Prioritize activities to meet objectives of studies and programs. Interact with Development Operations and supporting functions to ensure quality compliance across all aspects of clinical development; identify and mitigate potential clinical quality risks, escalation to management; leverage knowledge of clinical development to maintain program oversight and influence proactive quality management. Anticipate, influence, and determine present and future business needs in support of quality for drug development programs. Lead the effort to articulate and present an integrated cross‑functional and comprehensive quality strategy plan. Identify and implement balanced fit‑for‑purpose quality management; develop and recommend strategies and tactics for success. Identify and remove barriers that could impact program objectives, priorities, timelines, and quality; communicate risks and mitigations to management. Serve as the primary program quality liaison during health authority inspections. Qualifications Bachelor’s degree in a physical science, life science, nursing, pharmacy, or equivalent experience. 5+ years of pharmaceutical industry experience in GCP quality assurance, regulatory affairs, clinical development, or clinical operations (oncology‑specific a plus but not required); preferred 1+ year of GCP QA auditing experience. Successful progressive leadership experience motivating teams to anticipate and deliver strong results and to meet or exceed customer expectations. Strategic and operational problem‑solving abilities, with the capacity to resolve issues related to quality and compliance with global and local regulations, policies, and procedures. Demonstrated ability in strategic planning and cross‑functional execution. Proven track record utilizing core and technical competencies in managing projects to support clinical research. Strong understanding of global pharma, clinical development, and operational legal and regulatory environments. Experience in preparing and presenting key information. Comprehensive knowledge of interrelationships among other RDQA GXP functions and business functions to serve as a good business partner. Location This role can be located in North Chicago, IL; Irvine, CA; South San Francisco, CA; Worcester, MA; Dublin, Ireland; or Maidenhead, UK. Compensation and Benefits The compensation range described below reflects the range of possible base pay compensation that AbbVie believes in good faith it will pay for this role at the time of posting. Comprehensive benefits package including paid time off (vacation, holidays, sick), medical, dental, vision insurance, and 401(k) for eligible employees. Eligible to participate in our long‑term incentive programs. Pay and benefits are subject to modification at AbbVie’s discretion. Equal Opportunity Employer 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. #J-18808-Ljbffr BioSpace