Supplier Quality Audit Manager

Indivior•Richmond, VA

12d•Hybrid

About The Position

The GMDP Audit Manager is responsible for managing and maintaining the supplier qualification and maintenance processes for GMP and GDP commercial suppliers, ensuring compliance with global regulatory standards and company policies. This role involves planning and executing internal and external audits, overseeing supplier lifecycle management, and onboarding vendors to ensure clear compliance expectations and alignment with business needs. The GMDP Audit Manager will play a critical role in maintaining a compliant supply chain, optimizing vendor performance, and supporting the delivery of high-quality products. This role is hybrid in our Richmond, VA HQ.

Requirements

BS/BA Degree in Life Sciences, Pharmacy, or a related field.
Auditing experience in a regulated environment, such as healthcare, pharmaceutical, or medical device industries.
Broad experience in pharmaceutical manufacturing and distribution.
Experience with vendor management
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.
Problem-solving and decision-making skills.
Ability to work independently and collaboratively.
Strong focus on compliance and continuous improvement.
Willingness to travel internationally/domestically (approximately 25-40% of time, depending on audit schedule).

Nice To Haves

Familiarity with virtual pharmaceutical supply chain models is advantageous.
Audit certification (e.g., ISO 9001, GxP) is desirable but not essential.

Responsibilities

Develop and execute internal and external GMDP audit programs using a risk-based approach.
Ensure all audits comply with GMDP 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.
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.
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.
Train and mentor internal and external auditors to build a strong audit team.
Provide training on quality processes.
Lead process improvement initiatives within the GMP QA framework.
Manage UK Auditor

Benefits

Competitive PTO 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
Wellness programs as well as other discounts and perks