Sr. Specialist, Compliance QA

Sr. Specialist, Compliance QA 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. Position Overview The Sr. Specialist supports the Quality and Compliance systems at the Raleigh facility. This role is primarily responsible for authoring Annual Product Reviews (APRs), conducting site self‑inspections, managing Change Control and CAPA records, and authoring Quality Agreements. The Sr. Specialist will have a high level of interaction and influence within the site and is expected to drive improvements to the systems for which the role is responsible. Responsibilities Distribution of components, raw materials, and bulk product release of systems for use Develop, implement, and maintain systems and procedures to ensure a high level of inspection readiness and regulatory compliance Participate in multi‑functional project teams as a Quality Compliance representative as directed by the CQA Manager or Site Quality Director Develop and drive compliance initiatives based on new regulations, guidance documents, industry standards, and Indivior global procedures as they apply to the site Function as a change controller and CAPA manager for site records Facilitate the compilation of data and author the Annual Product Review reports Author Quality Agreements Create the self‑inspection schedule, perform self‑inspections, write audit reports, and follow up on observations and non‑conformances Participate in customer and regulatory audits, as required Participate in the review and approval of GMP documents including procedures, validation protocols, engineering documents and critical work orders Coordinate vendor‑initiated changes and vendor complaints Responsible for compiling and reporting metrics related to site compliance Perform QA review and approval of incoming materials in the ERP system, as required Provide support and guidance to ensure GDocs are applied throughout the Raleigh Site Track open records in eQMS to include deviations, environmental excursions, OOS investigations, CAPAs, and change controls to closure Design and implement action plans to ensure compliance with procedural requirements Perform lab data review as needed Other duties and responsibilities as assigned Qualifications Bachelor’s Degree in life sciences, engineering, or a related technical discipline from an accredited university Minimum five (5) years GMP/GXP Pharmaceutical experience In‑depth knowledge of current GMP/GXP as well as FDA trends and guidelines Experience authoring Annual Product Reviews Experience conducting internal audits (Certified Quality Auditor preferred) Excellent technical writing skills and technical reviewer experience Effective verbal and written communication with all levels of employees on all aspects of compliance In‑depth knowledge of quality assurance terminology, methods, and compliance tools Computer skills required; experience with Veeva preferred Experience reviewing lab data and audit trail data preferred Organized, detail‑oriented, capable of handling multiple tasks and redirecting focus based on company needs Adaptable to schedule changes, shifts in priority and cross‑functional task alignment Proficient in problem‑solving and risk mitigation Team focused, motivated and foster a positive and accepting environment Travel: Less than 10% travel Benefits Starting Salary: $88,000‑$108,000 USD (based on qualifications and experience) 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 Competitive PTO plus company closure from December 24th‑January 1st 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 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. 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. #J-18808-Ljbffr Indivior PLC