Auditor, RDQA Clinical Quality Audit - Remote

AbbVie Inc.; North Chicago (IL); Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Clinical QA Auditor to lead the execution of the Clinical audit program, including scheduling, planning and reporting to ensure global compliance with GCP and regulatory requirements. You will support RDQA, drive CAPs and participate in inspections, contributing to a robust quality system.

The role requires a Bachelor’s degree in a science or health field, 3–5 years in biopharma QA or clinical research, and the ability to travel internationally.

Qualifications

• Bachelor’s degree in science (physical, life, health) or healthcare profession or equivalent experience.
• 3–5 years in biopharmaceutical industry or with a regulatory authority.
• 3–5 years in Quality Assurance and/or Clinical Research Development.
• Strong analytical skills with data-driven conclusions.
• Ability to work independently in a dynamic environment.
• Knowledge of clinical trial regulations (ICH-GCP, EU directives).
• Willingness to travel internationally.

Responsibilities

• Assure quality and compliance in a regulated global environment through audit and QA oversight.
• Lead and participate in Clinical Audit scheduling, planning and conduct across sites, processes, systems and affiliates.
• Communicate audit results orally and in writing within target timeframes.
• Review and approve Corrective Action Plans and track actions to completion.
• Support development/maintenance of Quality standards for Clinical audit.
• Contribute to continuous improvement initiatives to ensure regulatory compliance.
• Participate in and support GCP inspections, as required.
• Provide guidance on GCP regulations to RDQA and business partners.
• Promote education on quality and clinical guidelines for AbbVie staff.

Skills

Analytical skills

Project management

Communication

Independent work

GCP knowledge

Attention to detail

Education

Bachelor’s degree in science or health field

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, 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

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 thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,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 short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssole 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

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

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