Director, Site Quality - Raleigh

**TITLE:**Director, Site Quality - Raleigh**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 Director of Quality - Raleigh is a critical part of the global quality organization, and is both a strategic and tactical, hands-on role. This position reports into the VP, Quality Management and is accountable for the quality site organization and the staff that fulfils its regulatory responsibilities by ensuring that all Indivior activities and commercial products, are compliant to Marketing Authorizations and cGxP requirements. The role holds site‐level accountability for sterility assurance, batch disposition, and patient safety in the highest‐risk manufacturing environment, consistent with Director‐level enterprise risk ownership. The role also acts as the primary site representative for FDA and global Health Authority inspections, commits the organization to remediation strategies, and owns critical compliance outcomes. The position scope includes QA, QC, microbiology, aseptic processing, validation, contamination control, training and site quality systems, with membership on the Site Leadership Team.This position will identify and resolve compliance issues in alignment with the global Quality function, implement continuous improvements, and drive a ‘culture of quality’ at the site. This position must also be able to secure and work cross functionally to support routine commercial manufacturing and compliant and safe drug products.**HOW YOU’LL MAKE AN IMPACT*** As a Member of the Quality Leadership Team (QLT), the Raleigh Leadership Team, (RLT) and the Site Quality Management Representative, manages and escalates quality and compliance issues to the VP, Quality Management; Director, Quality Ops and Raleigh Site Director, as applicable.* Has site decision authority to independently halt operations, reject product, and escalate compliance risks.* Develops site quality strategy to ensure continued release of complaint product in a streamlined manner ensuring product is available to patients without disruption.* Attracts, develops and leads the Quality functions at the site including Quality Assurance and Quality Control.* Provides strategic and tactical site level oversight for quality operations.* Assigns clear roles and responsibilities in the quality department to assure coverage of all fields of responsibility.* Provide quality oversite for QA, QC, microbiology, aseptic processing, validation, contamination control, training and site quality systems.* Responsible for ensuring site processes are in cGMP compliance and establish systems that identify opportunities for process improvement.* Develops knowledge of and understands regulatory requirements such as 21CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies that apply to the quality role.* Provides input into the Indivior Pharmaceutical Quality System reducing identified risks accordingly.* Ensures cGxP and process training is conducted to applicable site associates.* Establishes and measuring/ reporting on the effectiveness of the QMS.* Independently and objectively reports on product quality and compliance state-of-control of the site.* Establishes procedures and specifications for adequate manufacturing control.* Ensures that the site has a Document Management process for maintaining cGMP documents and records in a state of compliance.* Manages the performance of laboratory tests and examinations to established method and specifications.* Ensures investigations of non-conformance are conducted appropriately with root cause analysis performed.* Approves or rejects components, APIs, raw materials or intermediates.* Dispositions the product for release to customer.* Provides quality oversight and ensures compliance of external suppliers providing feedback to Indivior Audit team.* Serves as the primary contact to regulatory authorities for site inspections, compliance questions, and ongoing communication.* Interacts with relevant functions to assure appropriate systems are maintained and implemented for compliance to cGMPs* Ensures processes and products are in compliance to all local, state, federal, and international rules and regulations.* Identifies opportunities for continuous improvement to heighten quality.* Conducts periodic reviews for adequacy of policies and procedures to assist the business in the strengthening of the PQS and to meet current INDIVIOR and regulatory requirements.* In collaboration with the Indivior Quality Audit function, ensures approval of INDIVIOR Contractors responsible for raw materials, API, manufacture, packaging, testing, distribution, and cGxP critical service providers.* Manages internal and external documentation flow for QA activities including change management, deviations, laboratory investigations and non-conformances.* Ensures quality incidents are fully investigated, root cause analysis is defined and that CAPA(s) are implemented and monitored for effectiveness.* Ensures Quality Management Reviews are conducted periodically and report on the quality performance using KPI’s that measure QMS and regulatory compliance and drive improvement.* In collaboration with Quality Validation and Quality Operations, participates in Technology Transfer activities into commercial supply as required.* Manages cGxP critical events and any recalls/mock recalls conducted as per procedure.* Management of stability studies, as applicable.* Other responsibilities, as assigned.**WHAT YOU’LL BRING*** Bachelor of Science degree in a life science or engineering discipline. Post graduate degree is 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 the testing, manufacturing, and packaging of drug product, devices or combination products. Experience in 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, for both drug and combination products including management of product quality complaints.* Comprehensive understanding of key pharmaceutical and Quality Management processes, test method verifications/validations and manufacturing and packaging facility requirements is required.* Practical demonstrated application of drug/combination product regulatory requirements (e.g. EU GMP, WHO, PIC/S, CFR 21 CFR Part 210/211, 21 CFR Part 4, 21 CFR 820); Clinical Trial Regulations (ICH E6, E2A, E8 and 21 CFR Part 50) and GLP Regulations (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 and ability to communicate clearly to all levels of the business, via concise written or oral summaries to senior management.* Experience in production operations a plus.* Influencing skills in areas with no direct reporting authority.* Strong planning #J-18808-Ljbffr