Senior Auditor, Supplier Audit & Compliance

Allergan; Chicago, Northern (IL, KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie seeks a Senior Auditor, Audit and Compliance to perform comprehensive audits ensuring GMP compliance across AbbVie plants, affiliates, and suppliers. You will support supplier QA audits, validate CAPA effectiveness, and uphold regulatory standards to ensure quality, safety, and product readiness.

The role requires extensive QA/audit experience, strong communication, and the ability to coordinate cross-functional activities with procurement, SQA, and manufacturing teams.

Qualifications

• Bachelor’s Degree preferably in technical or scientific area or equivalent industry experience (at least 4 years) with exposure to pharmaceutical, medical device, biologics and related industries.
• 9+ years of total relevant experience in Quality Assurance including 6+ years and 3+ years in compliance/auditing is required.
• Technical background and understanding of QA audit processes and GMP regulations.

Responsibilities

• Assesses compliance of systems, facilities, and procedures per applicable regulations and AbbVie specifications.
• Provides audit observations and reviews corrective actions to verify effectiveness and closure.
• Collaborates with internal stakeholders to coordinate and conduct supplier and internal site audits.
• Ensures audits follow the annual audit schedule and supports readiness for product launches.

Skills

Audit & Compliance

Regulatory knowledge

Project management

Communication skills

Education

Bachelor's degree in technical/scientific field

Tools

ASQ Certification

Job description

Company 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, Xand YouTube.

Job Description

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 AbbVie plants, affiliates, quality service areas and/or suppliers that provide materials, services, and products to AbbVie. Responsible for providing support to AbbVie 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 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.
• 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 AbbVie 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 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.
• 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.
• Must have a technical background, including an understanding of Quality Assurance audit process and knowledge of worldwide requirements related to GM P 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.

Additional Information

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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