GMDP-GCP AuditorIndivior • Richmond, VA, US
No longer accepting applications
GMDP-GCP Auditor
Indivior • Richmond, VA, US
30+ days ago
Job type
- Full-time
Job descriptionBachelor's degree from an accredited university required. Minimum three (3) years auditing experience in a regulated environment, such as healthcare, pharmaceutical, or medical device industries. Broad experience in pharmaceutical manufacturing and distribution. In-depth knowledge of GCP regulations (e.g., ICH E6), FDA regulations, and other relevant guidelines governing clinical research. Proven experience conducting GCP audits, either as an internal auditor, sponsor representative, or independent consultant. Experience with vendor agreements and Quality Technical Agreements (QTAs). Familiarity with virtual pharmaceutical supply chain models is advantageous. Strong knowledge of EU GMP, GDP, FDA, and other regulatory requirements. Proven ability to manage audit programs, supplier qualifications, vendor agreements, and CAPAs. Exceptional organizational, communication, and leadership skills. Audit certification (e.g., ISO 9001, GxP) is desirable but not essential. Strong communication skills. Problem-solving and decision-making skills. Ability to work independently and collaboratively. Strong focus on compliance and continuous improvement.
GMDP / GCP Auditor
The GMDP / GCP Auditor is responsible for planning, conducting and reporting audits related to Good Manufacturing and Distribution Practices (GMDP) and Good Clinical Practices (GCP) ensuring compliance with global regulatory standards and company policies. This ensures that pharmaceutical, biotechnology, and clinical pharmaceutical, adhere to applicable guidelines, maintaining product quality, patient safety, and data integrity.
The responsibilities of this job include, but are not limited to, the following :
- Audit Program Management
- Supplier Qualification and Lifecycle Management
- Vendor Agreement Management
- CAPA and Risk Management
- Regulatory Compliance and Inspection Support
- Quality Systems and Metrics
- Leadership and Training
Minimum Qualifications :
Competencies / Conduct :
Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do.
Create a job alert for this search
Auditor • Richmond, VA, US
Related jobs
The position is described below.If you want to apply, click the Apply Now button at the top or bottom of this page.After you click Apply Now and complete your application, you'll be invited to crea...Show more
Does this position have telework options? -Telework options are subject to change based on business needs-.Does this position have a bilingual or multilingual skill requirement or preference?.Virgi...Show more
Here at Baylor Scott & White Health we promote the well-being of all individuals, families, and communities.Baylor Scott and White is the largest not-for-profit healthcare system in Texas that empo...Show more
Zurich North America is hiring a Premium Audit Auditor II to join our team! We are open to hiring talent in one of the following locations : Alabama, Arkansas, Connecticut, Delaware, Florida, Georgi...Show more
Summary General Summary : The Surgeon is responsible for performing surgical procedures to prevent or correct injuries and diseases of pediatric patients.
A high level of independence in performance ...Show more
Sparksoft Corporation is seeking a self-driven, deadline oriented, and numbers focused individual to join our finance team! This position will become an integrated part of the finance organization ...Show more
Argo Group International Holdings, Inc.American National, US based specialty P&C companies, (together known as BP&C, Inc.
Brookfield Wealth Solutions, Ltd.BWS"), a New York and Toronto-listed public...Show more
Principal Auditor (Experienced Senior Auditor), Consumer Lending Audit (Hybrid).Capital One's Audit function is a dedicated group of professionals focused on delivering top-quality assurance servic...Show more
For more than three decades the Virginia Lottery has worked to build a strong reputationone synonymous with providing fun entertaining experiences and doing so responsibly and with integrity.Procee...Show more
Universal is headquartered in Richmond, Virginia, and is the leading global leaf tobacco supplier.Tobacco sourcing and processing has been the Company's principal focus since its founding in 1918.T...Show more
Overview : A FSQ Auditing Specialist is the Lead SQF practitioner designated to oversee the development, implementation, review, and maintenance of the Plants Food Safety Quality Management System & ...Show more
This position is responsible for providing a best-in-class customer experience while processing transactions, servicing existing and potential customers, and contributing to branch sales goals.This...Show more
Join the City of Richmond! We are committed to nurturing talent, fostering growth opportunities, and building strong connections within our workforce.
As we continue to make strides to becoming the ...Show more
Become a part of our caring community and help us put health first.The Internal Audit Consulting Group drives the achievement of Humana's strategic and financial objectives.The Senior Internal Audi...Show more
Village Behavioral Health (VBH) is a licensed behavioral health organization providing crisis services.Our mission is rooted in the belief that it takes a village to foster healing, stability, and ...Show more
Here at Baylor Scott & White Health we promote the well-being of all individuals, families, and communities.Baylor Scott and White is the largest not-for-profit healthcare system in Texas that empo...Show more
Come grow with James River Insurance!.James River Insurance is an excess and surplus lines segment of James River Group Holdings, Ltd.
Since 2003, James River has provided thousands of commercial pr...Show more
The Office of the State Inspector General (OSIG) is seeking a qualified individual for the position of Senior Auditor within its Audit Division.
The purpose of the position is to plan and conduct pe...Show more
Sr Internal Auditor - Professional Practices
Truist Inc • Richmond, VA, United States
Full-time +2
Last updated: 17 days ago • Promoted
Senior Internal Auditor
Virginia Community College System • Richmond, VA, United States
Full-time +1
Last updated: 9 days ago • Promoted
Senior Internal Auditor
Baylor Scott & White Health • Richmond, VA, United States
Full-time
Last updated: 17 days ago • Promoted
Premium Audit Auditor II
Zurich NA • Richmond, VA, United States
Full-time
Last updated: 17 days ago • Promoted
Physician General Practitioner
Childrens Hospital Of The Kings Daughter • Doswell, VA, US
Full-time
Last updated: 1 day ago • Promoted
Mid-level Financial Analyst / Project Control
Sparksoft • Fort Lee, VA, United States
Full-time
Last updated: 25 days ago • Promoted
AVP, P&C Underwriting
Argonaut Management Services, Inc • Richmond, VA, United States
Full-time
Last updated: 30+ days ago • Promoted
Principal Auditor (Experienced Senior Auditor), Consumer Lending Audit (Hybrid)
Capital One • Richmond, VA, US
Full-time +1
Last updated: 30+ days ago • Promoted
Lead Casino Auditor
DHRM • Petersburg, Virginia, USA
Full-time
Last updated: 9 days ago • Promoted
Internal Auditor II
Universal Leaf Tobacco Company • Richmond, VA, United States
Full-time +1
Last updated: 6 days ago • Promoted
FSQ Auditing Specialist
Boar's Head Brand / Frank Brunckhorst Co., LLC • Petersburg, VA, United States
Full-time
Last updated: 18 days ago • Promoted
Teller-Floater (Bowling Green Branch)
Atlantic Union Bank • Bowling Green, VA, United States
Full-time
Last updated: 10 days ago • Promoted
Internal Auditor
City of Richmond, VA • Richmond, VA, United States
Full-time
Last updated: 13 days ago • Promoted
Senior Internal Auditor
Humana • Richmond, VA, United States
Full-time
Last updated: 7 days ago • Promoted
Crisis Clinician (LMHP-E)
Village Behavioral Health, Inc. • Colonial Heights, VA, United States
Full-time
Last updated: 5 days ago • Promoted
Senior Internal Auditor
Virginia Staffing • Richmond, VA, US
Full-time
Last updated: 5 days ago • Promoted
AVP, Reserving Actuary (Actuarial)
James River Management Company • Richmond, VA, United States
Full-time
Last updated: 30+ days ago • Promoted
Senior Auditor
Virginia Jobs • Richmond, VA, United States
Full-time
Last updated: 16 days ago • Promoted