Talent Pipeline Finance Lead, Audit

Job Overview

The function of Audit and Compliance Senior Auditor/Lead is to perform comprehensive audits for compliance with US and foreign regulatory requirements, providing constructive evaluation of quality related systems for Abb Vie plants, affiliates, quality service areas and/or suppliers that provide materials, services, and products to Abb Vie. Their execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with Abb Vie 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 Abb Vie and must achieve a difficult balance of involvement and objectivity.

• Assesses compliance of systems, facilities, and procedures per applicable regulations, assuring compliance to regulatory requirements and Abb Vie 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 Abb Vie 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 Abb Vie patients.

• 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 and written communication 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 the company as well as internal stakeholders across functional and technical areas.

• Salary range: $35,000 - $172,500. Payment may vary based on location and additional factors.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical, dental, vision insurance and a 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Abb Vie 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

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