Senior Auditor, Supplier Audit & Compliance

Company Description

About Abb Vie

Abb Vie'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 Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

The function of Senior Auditor, Audit and Compliance performs comprehensive audits for compliance with US and foreign regulation 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. Responsible for providing support to Abb Vie plants in the execution of supplier Quality Assurance Audits and the resolution of CAPA plans related to supplier Quality Assurance audits.

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.
• For supplier auditing, primarily focused on key suppliers whose processes are more comprehensive and critical to the business and will include potential participation in audits of Abb Vie plants.
• 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 of supply to Abb Vie patients.

• Bachelors 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.
• 9+ years of total relevant experience, including 6+ years in Quality Assurance with some project management experience in the pharmaceutical, medical device, biotechnology or related industry and 3+ years in compliance/auditing is required.
• Travel for this role is up to 40%.
• 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.

• 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…