AbbVie

Senior Auditor, Supplier Audit & Compliance

AbbVie$110K — $130K *
US-AnywhereRemote in Chicago, IL
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in a technical/scientific field or equivalent experience (4 years) in relevant industries.
  • 9+ years of experience in Quality Assurance, with 6+ years in QA roles and project management.
  • 3+ years of experience in compliance/auditing for regulated industries.
  • Strong understanding of GMP regulations and quality systems globally.
  • Excellent communication skills and ability to influence across various stakeholders.

Responsibilities

  • Assess compliance of systems and procedures with applicable regulations and AbbVie specifications.
  • Provide audit feedback and review corrective actions for effectiveness and adherence.
  • Participate in strategic initiatives to enhance compliance with regulatory standards.
  • Focus on auditing key suppliers with critical processes to AbbVie.
  • Collaborate with internal and external teams to coordinate joint audits.
  • Ensure audits follow the annual schedule to prevent product launch delays.
  • Monitor supplier audit activities to maintain a steady supply for AbbVie patients.

Benefits

  • Comprehensive benefits package including medical, dental, and vision insurance.
  • Generous paid time off including vacation, holidays, and sick leave.
  • 401(k) with company match for eligible employees.
  • Participation in long-term incentive programs.
Full 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 34; Assesses compliance of systems, facilities, and procedures per applicable regulations, assuring compliance to regulatory requirements and AbbVie specifications. 34; 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. 34; Participates in strategic initiatives to improve compliance to regulatory requirements and standards. 34; 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. 34; Collaborates with R&D QA to coordinate and conduct joint audits. 34; Communicates and coordinates supplier audit activities with internal stakeholders such as procurement, SQA, EQA, manufacturing sites and commercial affiliates as well as external stakeholders. 34; Ensures audits are conducted according to the annual audit schedule. 34; Ensures no product launch delays or business interruptions due to supplier audit delays thereby assuring of supply to AbbVie patients. Qualifications 34; 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. 34; 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. 34; Travel for this role is up to 40%. 34; 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. 34; 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. 34; Excellent oral/written communications skills. Must exhibit strong interpersonal skills, tact, open mindedness, maturity, tenacity, self-reliance, organizational/administrative skills, and sound judgment. 34; 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 or local law: 34; 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. 34; We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. 34; This job is eligible to participate in our long-term incentive programs. 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion, consistent with applicable law.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

Join Our Team

Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference.

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Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ

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