GMDP-GCP Auditor

Title:

GMDP-GCP Auditor

• Title: GMDP/GCP 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.

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· 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.

Vendor Agreement Management

• Track vendor performance against contractual obligations and escalate issues as needed.
• Support audit, inspections, and due diligences 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.

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).

• 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:

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

Specific Skills And Abilities:

• 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.

Key Competencies:

• Problem-solving and decision-making skills.
• Ability to work independently and collaboratively.
• Strong focus on compliance and continuous improvement.

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: 

• 3 weeks’ vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 
• 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay 
• U.S. Employee Stock Purchase Plan- 15% Discount 
• Comprehensive Medical, Dental, Vision, Life and Disability coverage 
• Health, Dependent Care and Limited Purpose Flex Spending and HSA options 

• Adoption Assistance

• Tuition Reimbursement

• Concierge/Personal Assistance Services

• Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage 
• Gym, fitness facility and cell phone discounts 

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:

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure 
• Risk IQ: Know what policies apply to your role and function and adhere to them. 
• Speak Up: If you see something, say something. 

Manager Obligations:

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure 
• Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. 
• Model and reinforce a Speak Up culture on your team. 

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