Supplier Quality Audit Manager

TITLE: Supplier Quality Audit Manager WHO 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. This role is hybrid in our Richmond, VA HQ. 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. 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  Eligible to participate in Indivior’s bonus program, based on company and individual performance Eligible to receive a yearly grant as part of Indivior’s Long-Term Incentive Plan 401(k) and Profit-Sharing Plan- Company match 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. #LI-AC1 Passion. Innovation. Achievement. All are key aspects of a career with Indivior. We are a worldwide family of individuals with varying backgrounds, strengths, and weaknesses united under one common purpose – the patient. The Indivior leadership team has built a global organization of individuals connected by a thriving culture. Our unique culture is a powerful driver of our ability to retain, develop, and recruit high performing talent while serving as the foundation for current success and future growth. It is our set of “Guiding Principles” that we believe have nurtured our culture and successfully guided our decision making. Indivior Guiding Principles: Focus on Patient Needs to Drive Decisions Believe that People’s Actions are Well Intended Seek the Wisdom of the Team Care Enough to Coach See it, Own it, Make it Happen Demonstrate Honesty and Integrity at All Times For those who are seeking a unique growth opportunity with a company that takes entrepreneurial approaches to creating value, we invite you to join us in our purpose to continue to pioneer life-transforming treatments for patients around the world. We look forward to hearing from you.