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Indivior · 3 months ago

GMDP Auditor

Richmond, VA

Full-time

Onsite

Mid Level

3+ years exp

Indivior is a global pharmaceutical company dedicated to transforming opioid use disorder into a recognized and treated chronic disease. The GMDP Auditor is responsible for planning, conducting, and reporting audits related to Good Manufacturing and Distribution Practices (GMDP) and Good Clinical Practices (GCP) to ensure compliance with global regulatory standards and company policies.

Addiction TreatmentBiotechnologyCommunitiesHealth CareMedicalPharmaceuticalSocial

Comp. & Benefits

Responsibilities

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-functionally with Quality, Clinical, Manufacturing, and Supply Chain teams to drive continuous improvement

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 escalate issues as needed

Support audit, inspections, and due diligence activities related to third-party vendors

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

Support preparation for regulatory inspections, ensuring audit documentation is accessible

Provide guidance during regulatory authority inspections of internal and external entities

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

Provide training on quality processes

Lead process improvement initiatives within the GMDP and GCP QA framework

Qualification

GMDP auditingGCP auditingRegulatory complianceSupplier qualificationCAPA managementRisk assessmentLeadership skillsCommunication skillsProblem-solving skillsOrganizational skills

Required

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

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

Strong communication skills

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

Preferred

Audit certification (e.g., ISO 9001, GxP) is desirable but not essential

Benefits

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