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 DescriptionThank you for considering a future opportunity with our company! We are not currently hiring for this specific role, but we would love to connect with talented individuals who are interested in potential future positions. By joining our talent pipeline, you will be the first to be notified when suitable opportunities arise.
In this talent pipeline requisition, we are not actively recruiting for this position at the moment. However, we are building a network of exceptional individuals who possess the skills and experience required for future openings. By submitting your application to this requisition, you will be added to our talent pipeline and considered for future opportunities.
QualificationsPurpose
The function of Audit and Compliance Senior Auditor/Lead is to 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. 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.
- 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 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.
- 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/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
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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. Salary: $35,000 - $172,500
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.
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
Skills Required
- Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or equivalent industry experience (at least 4 years)
- 6+ years of total relevant experience with at least 4+ years in Quality Assurance and 2+ years in compliance/auditing
- Experience with GMP regulations and worldwide quality/regulatory requirements
- Understanding of Quality Assurance audit processes and quality management principles
- Ability to assess systems, facilities, procedures and review corrective actions for effectiveness
- Experience coordinating supplier audits and working with procurement, SQA, EQA, manufacturing and affiliates
- Excellent oral and written communication and strong interpersonal skills
- ASQ certification
- Project management experience in pharmaceutical, medical device, biotechnology or related industry
- Ability to influence external and internal stakeholders across functional and technical areas
AbbVie Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.
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Retirement Support — 401(k) contributions include a dollar-for-dollar match up to 6% plus an additional annual company contribution tied to age and service. Company-paid life insurance and other financial protections further strengthen long-term security.
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Parental & Family Support — Paid leave programs include up to 12 weeks at 100% for parental leave and separate paid caregiver leave, with eligibility after six months where noted. Adoption and surrogacy reimbursements and family-building resources add further support.
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Healthcare Strength — Health coverage begins on day one with medical, dental, vision, mental health, and prescription benefits, and preventive care covered at 100%. Options such as HSAs/FSAs and coverage for spouses/domestic partners and children up to age 26 broaden accessibility.
AbbVie Insights
What We Do
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.
