GMDP Auditor; Pharma

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This range is provided by Insight Global. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$93,000.00/yr - $/yr

• 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.

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.

Audit Program Management

• Develop and execute internal and external GMDP and GCP audit programs using a risk-based approach.
• Ensure all audits comply with GMDP and GCP regulations and company standards.
• Manage audit resources, including internal and external auditors, and maintain a qualified auditor list.
• Prepare audit agendas, reports, and CAPA plans, ensuring timely documentation and follow-up.
• Monitor audit status, track CAPA implementation, and ensure issue resolution.
• Conduct audits of manufacturing, distribution, laboratories, investigator sites, CROs, and vendors against GMDP/GCP requirements.
• Collaborate cross-functionality with Quality, Clinical, Manufacturing, and Supply Chain teams to drive continuous improvement.

Supplier Qualification and Lifecycle Management

• Perform due diligence, initial qualification, requalification, and disqualification for suppliers.
• Maintain and update the Commercial GMDP Approved Supplier List (ASL).
• Oversee supplier transitions from R&D QA to Commercial QA during product launches.
• Ensure suppliers meet regulatory and business requirements throughout their lifecycle.
• Track vendor performance against contractual obligations and elevate issues as needed.
• Support audit, inspections, and due diligence activities related to third-party vendors.

CAPA and Risk Management

• Develop and manage CAPA plans with auditees, ensuring timely resolution of non-conformances.
• Suspend or withhold supplier qualifications for unresolved critical risks.
• Conduct risk assessments and implement mitigation strategies.

Regulatory Compliance and Inspection Support

• Support preparation for regulatory inspections, ensuring audit documentation is accessible.
• Provide guidance during regulatory authority inspections of internal and external entities.

Quality Systems and Metrics

• Develop and maintain quality audit systems, ensuring adherence to relevant standards.
• Publish audit metrics and KPIs, including supplier risks and CAPA performance.
• Report audit outcomes and risks during management reviews.

Leadership and Training

• Provide training on quality processes.
• Lead process improvement initiatives within the GMDP and GCP QA framework.

Mid-Senior level

Full-time

Accounting/Auditing

Pharmaceutical Manufacturing

• 401(k)
• Vision insurance
• Medical insurance