Company 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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose

The Manager, QA Audit and Compliance will perform evaluations for compliance with US and foreign regulation requirements (minimally may include the Americas, Asia, Africa, Australia, European Middle East regions) and provide constructive evaluation of quality related systems for suppliers that provide materials, services and products to AbbVie. Suppliers can include API suppliers, contract labs, excipient suppliers, commodity suppliers and third party manufacturers. 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. Lead teams to achieve key process improvement deliverables.

Responsibilities

Assess compliance of systems, facilities, and procedures per applicable regulations through audits and assessments of our suppliers, assuring compliance to regulatory requirements and AbbVie specifications.Provide feedback in the form of audit observations, formulate recommendations, and review corrective actions to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained at the supplier.Assess suppliers using Risk Management tools to assign the corresponding level of risk, audit observation, and overall audit outcome ratings.The position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement and objectivity.Participate in strategic initiatives to improve compliance to regulatory requirements and standards.Lead Cross-functional teams within the Quality and Compliance Global organizations to ensure key deliverables for process improvements are achieved.
Qualifications
Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering)6 years in Quality Assurance, Compliance and Auditing with project management experience within the pharmaceutical, medical device, or combination product.Must have a technical background and requires understanding of the 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.The individual must have excellent oral/written communications skills both in English & Spanish.3+ years of experience in Leading Teams of direct reports.
Additional Information

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

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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 short-term incentive programs. ​​

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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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html