Lead Quality Dossier Program Auditor - Hybrid, Chicago

AbbVie Inc.; North Chicago (IL); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Job summary

AbbVie is seeking a Quality Assurance Auditor to plan and conduct audits across clinical, pre-clinical, and CMC documentation within the Quality Dossier Program. You will review responses, maintain schedules, and represent RD QA in cross-functional meetings to drive compliance and continuous improvement.

Required is a 5+ year background in pharma/medical devices with QA or RA exposure; strong communication and collaboration skills are essential to coordinate audits and related activities across

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 during audits.
• Coordinating review and tracking of audit responses across multiple dossier programs.
• Managing audit program activities including schedule, metrics, and leadership reporting.
• Escalating potential quality issues to management.
• Assist in Due Diligence and Post-Closure Quality activities.
• Assist in coordination of RDQA activities.

Responsibilities

• Plan and conduct audits required by the Quality Dossier Program.
• 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 action plans for 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

Quality Assurance auditing

Regulatory Affairs

Cross-functional collaboration

Audit programme coordination

Documentation review

Education

Bachelor’s degree in physical science, life science, pharmacy, engineering, or equivalent experience

Job 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 at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

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 & Experience

• 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.

Compensation & Benefits

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

Equal Opportunity

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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html