Company Description
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. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atย www.abbvie.com. Follow @abbvie onย LinkedIn,ย Facebook,ย Instagram,ย Xย andย YouTube.
Job Description
The Lead Quality Dossier Program Auditor role supports the Quality Dossier Program audit process by planning and conducting audits required by the Quality Dossier Program. This includes effectively communicating and interacting with business partners, e.g., Medical Writing; Regulatory Affairs; Development Sciences, etc., during the audit process and managing other aspects of the audit program, including maintaining the audit schedule, reporting metrics, presenting to Senior Leadership as needed.
Responsibilities:
- Plan and conduct audits required by the Quality Dossier Program.ย 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
- Bachelorโs degree preferable in a physical science, life science, pharmacy, engineering, or equivalent experience required.
- 5+ yearsโ experience in the Medical Device or Pharmaceutical industry,
- Experience in Quality Assurance or Regulatory Affairs (preferred)
- Quality Assurance auditing experience (preferred)
- Planning and conducting audits required by the Quality Dossier Program
- Effectively communicating and interacting with business partners, e.g., Medical Writing; Regulatory Affairs; Development Sciences, etc., 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
- Assist in the management of Due Diligence and Post-Closure Quality Assessment 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 Quality assessments.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orย local law:ย โ
- The compensation range described below is the range of possible base pay compensation that the Companyย believes inย good faith it will pay for this role at the timeย of this posting based on the job grade for this position.ย Individualย compensation paid within this range will depend on many factors including geographic location, andย weย mayย ultimatelyย payย more or less than the posted range. This range may beย modifiedย in theย future.ย โ
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),ย medical/dental/visionย insurance and 401(k) to eligibleย employees.โ
- This job is eligible toย participateย in our long-term incentiveย programs.
Note: No amount of payย is considered to beย wages or compensation until such amount is earned, vested, andย determinable.ย The amount and availability of any bonus,ย commission, incentive, benefits, or any other form ofย compensation and benefitsย that are allocable to a particular employeeย remainsย in the Company’s sole andย absoluteย discretion unless and until paid andย may beย modifiedย at the Companyโs sole and absolute discretion, consistent withย applicable law.โ
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.โฏ Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visitย https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
