Senior Manager, Clinical Quality Assurance - Americas

Role: Senior Manager, RDQA AREA supporting global clinical research quality assurance within AbbVie's R&D organization, focusing on proactive quality management in designated countries across Europe, Americas, and Intercontinental regions. Objectives include ensuring compliance, driving quality excellence, and facilitating successful first-pass approvals of clinical trials. Responsibilities encompass collaborating with clinical development teams, implementing risk mitigation strategies, overseeing audits and inspections, and maintaining regulatory readiness aligned with local and global standards. Requirements include a Bachelor's in Biology, Nursing, Pharmacy, or related field, with 8+ years in biopharmaceutical quality assurance, compliance, or regulatory roles, including at least 3 years in leadership. Strong knowledge of GxP, quality systems, and regulatory landscapes is essential. Preferred skills involve effective influence, negotiation, cross-functional collaboration, and experience supporting clinical trials in regulated environments. High-value specifics: focus on clinical research quality in multi-region global trials, supporting complex development pipelines, and ensuring inspection readiness for health authorities. The role involves up to 35% travel and is based in any of AbbVie's US locations, with a hybrid work setup.