GMDP Auditor

TITLE : GMDP Auditor

Title : GMDP Auditor

Reports To : Head of Global Quality, GxP Audit Programmes

Location : Richmond, VA

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com / company / Indivior.

POSITION SUMMARY :

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.

ESSENTIAL FUNCTIONS :

The responsibilities of this job include, but are not limited to, the following :

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

Vendor Agreement Management

CAPA and Risk Management

Regulatory Compliance and Inspection Support

Quality Systems and Metrics

Leadership and Training

Other duties as assigned

MINIMUM QUALIFICATIONS :

License / Certifications : N / A

Travel : Willingness to travel internationally / domestically (approximately 25-40% of time, depending on audit schedule).

COMPETENCIES / CONDUCT :

In addition to the minimum qualifications, the employee will demonstrate :

Specific Skills and Abilities :

Key Competencies :

BENEFITS :

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes :

GUIDING PRINCIPLES :

Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

COMPLIANCE OBLIGATIONS :

Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to :

Employee Obligations :

Manager Obligations :

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY

EOE / Minorities / Females / Vet / Disabled