Director, Site Quality - Raleigh

Director, Site Quality - Raleigh Indivior is a global pharmaceutical company dedicated to developing medicines for Opioid Use Disorder (OUD). The Director of Quality at our Raleigh site plays a strategic and tactical role within the global quality organization, reporting to the VP, Quality Management. The position holds site‑level accountability for sterility assurance, batch disposition, and patient safety in a high‑risk manufacturing environment, and serves as the primary site representative for FDA and global Health Authority inspections. Responsibilities Hold site‑level accountability for sterility assurance, batch disposition, and patient safety. Act as the primary site representative for FDA and global Health Authority inspections, committing the organization to remediation strategies and owning critical compliance outcomes. Provide strategic and tactical site level oversight for quality operations across QA, QC, microbiology, aseptic processing, validation, contamination control, training, and site quality systems. Identify and resolve compliance issues in alignment with the global Quality function, implementing continuous improvements and driving a culture of quality at the site. Secure and work cross‑functionally to support routine commercial manufacturing and compliant safe drug products. Develop and execute the site quality strategy to ensure continued release of complaint product in a streamlined manner, keeping products available to patients without disruption. Attract, develop and lead Quality functions at the site, including QA, QC, microbiology, aseptic processing, validation, contamination control, training and site quality systems. Assign clear roles and responsibilities within the quality department to assure coverage of all fields of responsibility. Ensure site processes are in cGMP compliance and establish systems that identify opportunities for process improvement. Provide input into the Indivior Pharmaceutical Quality System, reducing identified risks accordingly. Ensure cGxP and process training is conducted for applicable site associates. Establish and measure/report on the effectiveness of the QMS. Independently and objectively report on product quality and compliance status of the site. Establish procedures and specifications for adequate manufacturing control. Maintain a Document Management process for cGMP documents and records in compliance. Manage the performance of laboratory tests and examinations to established methods and specifications. Ensure investigations of non‑conformance are conducted appropriately with root cause analysis performed. Approve or reject components, APIs, raw materials or intermediates; disposition product for release to customer. Provide quality oversight and ensure compliance of external suppliers; provide feedback to the Indivior Audit team. Serve as the primary contact to regulatory authorities for site inspections, compliance questions, and ongoing communication. Interact with relevant functions to assure appropriate systems are maintained and implemented for cGMP compliance. Ensure processes and products comply with all local, state, federal, and international rules and regulations. Identify opportunities for continuous improvement to heighten quality. Conduct periodic reviews for adequacy of policies and procedures to strengthen the PQS and meet current Indivior and regulatory requirements. Approve Indivior contractors responsible for raw materials, API, manufacture, packaging, testing, distribution, and critical service providers. Manage internal and external documentation flow for QA activities including change management, deviations, laboratory investigations, and non‑conformances. Ensure quality incidents are fully investigated, root cause analysis is defined, and CAPA(s) are implemented and monitored for effectiveness. Ensure Quality Management Reviews are conducted periodically and report on quality performance using KPIs that measure QMS and regulatory compliance and drive improvement. Collaborate with Quality Validation and Quality Operations in Technology Transfer activities into commercial supply as required. Manage cGxP critical events and any recalls/mock recalls conducted as per procedure. Manage stability studies as applicable. Perform other responsibilities as assigned. Qualifications Bachelor of Science degree in a life science or engineering discipline; postgraduate degree preferred. Proven track record in a direct leadership role within pharmaceutical, biopharma or biologics industries, with emphasis on sterile DP manufacture and testing. Evidence of successful history in Health Authority inspections and follow‑up. Thorough understanding of regulatory requirements for testing, manufacturing, and packaging of drug product, devices or combination products. Experience with product manufactured for the US, EU and Asia. Clear understanding of cGxP requirements and ability to assess and act upon product safety, quality, efficacy, and compliance risks. Comprehensive understanding of key pharmaceutical and Quality Management processes, test method verifications/validations, and manufacturing and packaging facility requirements. Practical application of drug/combination product regulatory requirements (EU GMP, WHO, PIC/S, CFR 21 CFR Part 210/211, 21 CFR Part 4, 21 CFR 820; ICH E6, E2A, E8, 21 CFR Part 50; Directive 2004/9/EC, 21 CFR 58). Prior experience managing contract and/or outsourced organizations is a definite plus. Experience in hosting Competent Authority inspections and communicating with Competent Authority Inspectors and officials. Strong analytical and problem‑solving ability. Experience in managing Controlled Substances. Strong interpersonal skills; ability to communicate clearly to all levels of the business, via concise written or oral summaries to senior management. Experience in production operations (plus). Supporting skills: Influencing skills with no direct reporting authority, planning and organization, auditing skills and appropriate qualifications in auditing. Motivation to deliver high quality patient treatments in the arena of addiction. Proficient in English; fluency in other languages is advantageous. Benefits 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. 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. Equal Employment Opportunity Equal Employment Opportunity (EEO): Minorities, Females, Veterans, Disabled individuals are encouraged to apply. #J-18808-Ljbffr Indivior PLC