Auditor, RDQA Clinical Quality Audit - Remote

Regulatory Jobs; Florham Park (NJ); Remote; USD 95,000 - 135,000; Full time

Benefits offered by this job

Paid time off (vacation, holidays, etc

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Clinical Audit Lead to execute the audit program, schedule, plan, report and resolve audits while ensuring adherence to RDQA policies. You will advise on GCP and quality topics for global business partners to ensure worldwide regulatory compliance.

You will contribute to the AbbVie Quality System, drive CAPA activities, and participate in inspections. Travel up to 40% is required to cover audits across sites and affiliates.

Qualifications

• Bachelor’s degree in science or healthcare field.
• 3–5 years in biopharmaceutical industry or regulatory authority.
• 3–5 years in Quality Assurance and/or Clinical Research Development.
• Strong analytical skills with data-driven conclusions.
• Willingness to travel internationally (up to 40%).

Responsibilities

• Assure quality and compliance in a regulated environment worldwide.
• Lead clinical audit scheduling, planning and conduct activities.
• Effectively communicate audit results, orally and in writing.
• Review and approve CAPAs and track actions to completion.
• Advance the AbbVie Quality System and support development of QA standards.
• Contribute to continuous improvement initiatives and inspections.
• Provide support on GCP regulations to RDQA partners.
• Promote education on quality and clinical guidelines.

Skills

Quality Assurance

Regulatory knowledge

GCP awareness

Audit coordination

Education

Bachelor’s degree in science or healthcare

Job 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, visit www.abbvie.com.

Role Overview

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%

Compensation & Benefits

• The compensation range is the range of possible base pay the Company believes in good faith it will pay for this role at the time of posting based on the job grade. Individual compensation will depend on many factors including geographic location.


• 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.

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