Lead Quality Dossier Program Auditor

Internationalinsuranceprofessionals; Chicago (IL); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Paid time off

Medical insurance

Dental insurance

401(k)

Job summary

AbbVie in Chicago seeks a Lead Quality Dossier Program Auditor to plan and conduct audits for the Quality Dossier Program. You will collaborate with Medical Writing, Regulatory Affairs, Development Sciences, and other partners to ensure timely, accurate audits and reporting to leadership.

The role requires strong audit planning, attention to detail, and the ability to manage multiple dossier programs while maintaining the audit schedule and providing metrics-driven updates to Senior Leadership.

Qualifications

• Bachelor's degree 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)
• Planning and conducting audits required by the Quality Dossier Program
• Effectively communicating and interacting with business partners during the audit process
• Coordinating the review and tracking of audit responses across multiple dossier programs
• Managing other aspects of the audit program including maintaining the audit schedule and reporting metrics
• Escalating potential quality issues to management

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 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.

Skills

QA auditing

Regulatory Affairs

Medical Writing liaison

Cross-functional collaboration

Quality systems

Education

Bachelor's degree in physical science / life science / pharmacy / engineering

Job description

ICompany Description

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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and 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. 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)
• 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

• 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 long-term incentive programs.

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.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html