Quality Dossier Auditor

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. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

This position sits onsite at our North Chicago, IL headquarters 3 days weekly.

Purpose:

Primarily goal of this position is an incumbent capable of supporting the Quality Dossier Program audit process by:

• Planning and conducting audits required by the Quality Dossier Program
• 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.
• Managing other aspects of the audit program, including maintaining the audit schedule, reporting metrics, presenting to Senior Leadership as needed.
• Escalating potential quality issues to management

Secondary goal, as needed:

• Assist in the management of Due Diligence and Post-Closure activities in support of projects across one or more aspect of the business.
• Assist in the coordination, review, and tracking of RDQA activities needed to complete Due Diligence and Post-Closure assessments.

Responsibilities:

• Plan and conduct audits required by the Quality Dossier Program.  Audits may be of clinical documents, pre-clinical documents, CMC documents, etc.

• Perform peer reviews of document audits.
• Review audit responses for adequacy, consistency, and compliance
• Maintain the audit schedule
• Represent RD QA for Dossier Program related meetings/activities/functions as needed.
• Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues
• Identify and resolve problems through effective interpersonal skills.
• Work independently as well as part of a team
• Maintain effective communication of program related information.

Qualifications:

• Bachelor’s degree preferable in a physical science, life science, pharmacy, engineering, or equivalent experience required.

• 5+ years’ experience in the Medical Device or Pharmaceutical industry,
• Experience in Quality Assurance or Regulatory Affairs (preferred)
• Quality Assurance auditing experience (preferred)
• 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.)

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

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AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.