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AbbVie

Auditor, RDQA Clinical Quality Audit

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Job Description

ENGLISH ENGLISH ESPAÑOL FRANÇAIS 中文(中国) 中文(台灣) DEUTSCH ITALIANO 日本語
NEDERLANDS
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PORTUGUÊS (BRAZIL) Auditor, RDQA Clinical Quality Audit -
Remote Florham Park, NJ Function:
Research & Development Work location type: Remote
Job Type:
Full-time
Job ID:
R00150912
APPLY SAVE 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, X and YouTube. Job Description Primarily responsible for the execution of the Clinical audit program, including scheduling, planning, reporting and resolution of Clinical audits. Ensuring alignment with RDQA policies and procedures wherever possible and contributing to the development and implementation of the Clinical QA quality system. Provision of advice and support on GCP and quality topics to business partners to ensure compliance with worldwide requirements and expectations.
Responsibilities:
Assure quality and compliance in a regulated environment that includes worldwide regulations, country specific and other applicable standards and AbbVie policies and procedures by continuous evaluation of Clinical processes through audit and QA oversight activities. Lead and participate in Clinical Audit scheduling, planning and conduct activities to assess compliance with regulations, guidelines, AbbVie policies and procedures and sponsor requirements. Clinical audit types include investigator clinical site, process, system and Affiliate audits. Effectively communicate audit results, both orally and in writing, within target timeframes. Review and approve Corrective Action Plans submitted in response to audit observations within target timeframes and tracking of actions to completion. Advance the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance requirements. Supports maintenance or development of Quality standards relating to Clinical audit. Contribute to continuous improvement initiatives/projects to help assure compliance to regulations and corporate policies. Participate in and support GCP inspections, as required. Provide support and consultation to RDQA and business partners with regards to GCP regulations. Promote continuous education on quality and clinical guidelines and regulations for self and other AbbVie staff. Qualifications Bachelor's degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience 3-5 years of experience in the biopharmaceutical industry or with a regulatory authority 3-5 years of experience in Quality Assurance and/or Clinical Research Development Strong analytical skills and the ability to draw conclusions from presented data Ability to work effectively and efficiently in a dynamic environment with minimal supervision High level of awareness and understanding of clinical trial regulations (e.g.
ICH-GCP, EU
Clinical Trial Directive/Regulation) and industry best practices Flexibility to adapt to changing assignments and ability to effectively prioritize Good project management, interpersonal, and communication skills with ability to work independently and as part of a team Willingness and ability to perform international travel Travel up to 40% Additional Information 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. ​ 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 Recruitment Fraud Alert We have recently become aware of various recruitment phishing scams targeting job seekers.
Please be advised:
AbbVie will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process. If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks. If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please contact us immediately. Protect yourself by verifying job offers and communications. Your safety is important to us.
Pay Range:
$ 84500 - 162000 USD Where We Work Role is not performed at a site or office and requires limited or no travel to a site or office. APPLY SAVE Share this job: Who we are Science Patients Join us Sustainability Unless otherwise specified, all product names appearing in this internet site are trademarks owned by or licensed to AbbVie Inc., its subsidiaries or affiliates. No use of any AbbVie trademark, trade name, or trade dress in this site may be made without the prior written authorization of AbbVie Inc., except to identify the product or services of the company. Copyright © 2026 AbbVie inc. North Chicago, Illinois, U.S.A
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Benefits

  • Paid Time Off (PTO)
  • Sick Leave
  • 401(k) Plans
  • Health Insurance