TITLE:
Supplier Quality Audit ManagerWHO WE ARE
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 an exploratory pipeline of products designed to expand its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.
POSITION SUMMARY:
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.
HOW YOU WILL MAKE AN IMPACT:
The responsibilities of this role include, but are not limited to, the following:
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
WHAT YOU WILL BRING:
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
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.
Audit certification (e.g., ISO 9001, GxP) is desirable but not essential.
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).
HOW WE INVEST IN OUR PEOPLE
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:
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
OUR SHARED RESPONSIBILITY FOR ETHICAL CONDUCT
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 behavior.
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.
EQUAL EMPLOYMENT OPPORTUNITY
EOE/Minorities/Females/Vet/Disabled are encouraged to apply!
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.
Want to learn more? Connect with us at www.indivior.com or follow us at www.linkedin.com/company/Indivior.
Top Skills
What We Do
Indivior is a global pharmaceutical company working to help change patients’ lives by developing medicines to treat substance use disorder and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of addiction. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid dependence treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of addiction, including alcohol use disorder. Headquartered in the United States in Richmond, VA, Indivior employs more than 800 individuals globally and its portfolio of products is available in over 40 countries worldwide. Our guiding principles foster a corporate culture of trust, innovation, and a pioneering spirit: • Focus on patient needs to drive decisions • Seek the wisdom of the team • Believe that people’s actions are well intended • Care enough to coach • See it, own it, make it happen • Demonstrate honesty and integrity at all times
