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.