Jobs at Abbvie – Lead Quality Dossier Program Auditor

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

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