Talent.com
GMDP-GCP Auditor

GMDP-GCP Auditor

IndiviorRichmond, VA, US
15 days ago
Job type
  • Full-time
Job description

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 :

  • Bachelor'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.

    • Competencies / Conduct :

  • 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.

    • 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