Job Description: AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Responsibilities: Planning and conducting audits required by the Quality Dossier Program Plan and conduct audits required by the Quality Dossier Program. Audits may be of clinical documents, pre-clinical documents, CMC documents, etc. Assist in the coordination, review, and tracking of RDQA activities needed to complete Due Diligence and Post-Closure assessments. Escalating potential quality issues to management Managing other aspects of the audit program, including maintaining the audit schedule, reporting metrics, presenting to Senior Leadership as needed. Effectively communicating and interacting with business partners, e.g., Medical Writing; Regulatory Affairs; CMC Coordination during the audit process. Coordinating the review and tracking of audit responses and associated tasks across multiple dossier programs. Perform peer reviews of document audits. Assist in the management of Due Diligence and Post-Closure activities in support of projects across one or more aspect of the business. Review audit responses for adequacy, consistency, and compliance Job Requirements: Demonstration of strong leadership competencies, proficient level of technical capabilities and independence, including familiarity with CMC (preferred) Understanding of international GxP regulatory standards (e.g., GMP, GLP, GCP, GDP, etc.) Qualification & Experience: 5+ years’ experience in the Medical Device or Pharmaceutical industry, Quality Assurance auditing experience (preferred) Experience in Quality Assurance or Regulatory Affairs (preferred) Bachelor’s degree preferable in a physical science, life science, pharmacy, engineering, or equivalent experience required. Job Details: Company: Abbvie Vacancy Type: Full Time Job Location: Rockford, IL, US Application Deadline: N/A Apply Here vacanciesforyou.net
Vacancies For You | Latest Job Opportunities 2025
