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AbbVieNorth Chicago, IL, US

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Audit And Compliance Senior Auditor / Lead

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.

Thank you for considering a future opportunity with our company! We are not currently hiring for this specific role, but we would love to connect with talented individuals who are interested in potential future positions. By joining our talent pipeline, you will be the first to be notified when suitable opportunities arise.

In this talent pipeline requisition, we are not actively recruiting for this position at the moment. However, we are building a network of exceptional individuals who possess the skills and experience required for future openings. By submitting your application to this requisition, you will be added to our talent pipeline and considered for future opportunities.

Purpose

The function of Audit and Compliance Senior Auditor / Lead is to perform comprehensive audits for compliance with US and foreign regulation requirements, providing constructive evaluation of quality related systems for AbbVie plants, affiliates, quality service areas and / or suppliers that provide materials, services, and products to AbbVie. Their execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with AbbVie policies / procedures and applicable quality and regulatory requirements intended to assure the quality, effectiveness, and safety of our products. This position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement and objectivity.

Responsibilities

Assesses compliance of systems, facilities, and procedures per applicable regulations, assuring compliance to regulatory requirements and AbbVie specifications.
Provides feedback in the form of audit observations and reviews corrective actions to determine if commitments have been properly implemented, are proven to be effective, and are being maintained at the supplier or internal AbbVie site. For internal sites, formulates recommendations for corrective actions.
Participates in strategic initiatives to improve compliance to regulatory requirements and standards.
Collaborates with R&D QA to coordinate and conduct joint audits.
Communicates and coordinates supplier audit activities with internal stakeholders such as procurement, SQA, EQA, manufacturing sites and commercial affiliates as well as external stakeholders
Ensures audits are conducted according to the annual audit schedule.
Ensures no product launch delays or business interruptions due to supplier audit delays thereby assuring supply to AbbVie patients.

Qualifications

Bachelor's Degree, preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 4 years) with sufficient exposure to pharmaceutical, medical device, biologics and combination products, cosmetics, eye care or aesthetics related industries. ASQ certification desired.

6+ years of total relevant experience, including 4+ years in Quality Assurance with some project management experience in the pharmaceutical, medical device, biotechnology or related industry and 2+ years in compliance / auditing is required.

Must have a technical background, including an understanding of Quality Assurance audit process and knowledge of worldwide requirements related to GMP regulations for quality systems and compliance.

Must understand a variety of quality / operational systems that support facility, product design, development, production, distribution, installation, support, and service and understand the principles of quality management

Excellent oral / written communications skills. Must exhibit strong interpersonal skills, tact, open mindedness, maturity, tenacity, self-reliance, organizational / administrative skills, and sound judgment.

Must be able to effectively communicate and influence others outside of the company as well as internal stakeholders across functional and technical areas

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 abbvie.com / join-us / equal-employment-opportunity-employer.html

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

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Join Our Talent Pipeline • North Chicago, IL, US