TITLE: Sr Director, Quality Operations, EMEA & API Manufacturing Title: Sr Director, Quality Operations, EMEA & API Manufacturing Reports To: VP, Quality Management Location: Slough, UK Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Indivior was founded to help tackle the opioid crisis, one of the largest and most urgent public health emergencies of our time. Our purpose is to bring science-based, life-transforming treatments to patients. We strive to help eliminate the stigma of addiction. We take our role as a responsible steward extremely seriously and commit ourselves to cultivating our unique culture and highest standards of integrity. We are driving forward our understanding of addiction and other serious mental health illnesses to create new science that will help pave the way for an even deeper understanding of patient needs and treatment innovation. We engage at all levels across the addiction treatment spectrum, interacting with governments, key opinion leaders, physicians, payers, patients, and patient advocacy groups to raise awareness and educate about addiction as a chronic, relapsing disease. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior. POSITION SUMMARY: The Sr. Director of Quality Operations EMEA & API Manufacturing is a critical part of the global quality organization, and is both a strategic and tactical, hands-on role. Reporting to the Vice President of Global Quality, this position has overall responsibility for EMEA compliance, Fine Chemical Plant (FCP) Quality performance and EMEA Quality Operations performance. Facilitating the implementation of and enhancement of Continuous improvement programs at all contract manufacturers / services suppliers / FCP to ensure ongoing improvement in our Quality network. This role will build relationships and manage interfaces with supporting organisations (CM’s, Services providers, Regulatory, Medical, CMC, NA Quality etc) and organisations supported by EMEA Quality (Commercial EUCAN, Supply Chain etc.) including improved ways of working. The position is also key in helping to sustain the global Pharmaceutical Quality System. Most importantly, the position helps to drive a ‘culture of quality’ at Indivior. ESSENTIAL FUNCTIONS: The responsibilities of this role include, but are not limited to, the following: Ensures all functions in EMEA business understand their role in delivering Quality Patient Care. Working with Supply Chain to determine batch disposition priorities to minimize patient impact. Commercial Quality Assurance activities for EMEA region including personnel and budget. Ensures all API Manufacturing activities at the FCP maintain compliance with stated regulatory, environmental, and Indivior internal requirements. Commercial product QP release supporting patients’ markets supplied from EMEA and North America region. Quality Assurance data base and documentation systems supporting EMEA commercial activities. Tech Transfer of products into the commercial Pharmaceutical Quality System, PQS, as applicable. Provides strategic and tactical level oversight for quality operations in EMEA and FCP API Manufacturing and Testing. Responsible for providing quality support to all EMEA regions/countries where NA manufactured product is distributed. Ensures all facilities and contract manufacturers operate in a state of quality compliance to ensure all product that is manufactured is safe, efficacious and effective for intended patient treatment. Develops and leads the EMEA quality team to ensure proper roles and responsibilities; development of personnel; establishment of succession planning; and, to ensure collaboration across all supported functions. Integrates quality oversight and operations effectively with NA and AuA Regions to ensure compliant, yet efficient release and disposition of drug products globally. Responsible for effective budget planning, driving costs of quality, and identifying continuous improvement opportunities within the supply chain and quality system. Maintenance and development of Area and local Indivior Pharmaceutical Quality System (procedures and working practices) to meet Indivior and Competent authority requirements. Leads diligence and compliance support for new product market entries. Provides strategic and tactical level oversight for quality operations in the UK, Europe, Middle East and African regions. Key member of the Quality Leadership Team (QLT). Escalation of product and process quality issues and identified risks to the QLT and Supply Leadership Team (SLT) and Indivior Quality Council (IQC) as appropriate. Accountable for ensuring Launch and Annual Product Stability programs and the release of Finished Product from EMEA Contractors and confirmation imported product meets EMEA or territory requirements. QA approval of GxP processes in the EMEA Business as well as Global PV Operations processes. Responsible for basic quality operational functions such as, but not limited to investigations; product acceptance and release; product quality reviews; management reviews; CAPA/continuous improvements; documentation systems and like responsibilities. Reporting of key metrics (KPIs), periodic quality reports, and audits as needed. Technology transfer QA activities into commercial supply. Management of GxP critical events and any EMEA recall. Management of Quality Data Base and Documentation applications for EMEA to ensure compliant delivery of master instruction documents, Change Control, Risk Management, Deviation, Investigation and CAPA systems activities. Management of Product Complaints. Hosting key regulatory inspections and supporting at key suppliers for the same. Drug Product and API that is manufactured, packaged and delivered is safe and effective, and meets all regulatory compliance requirements internationally. Working in compliant, yet efficient ways with the regional QPs to ensure effective export/import operations of drug product. Establishing and sustaining a culture of quality at Indivior and all key suppliers. PQS meets regulatory authority expectations to ensure continued support of all licences and certifications related to commercial GxP activity. Quality essential training delivered to correct job roles and competency confirmed to ensure patient supply, compliant and effective activity within the PQS. Approval of Technology Transfer of products to ensure smooth introduction into commercial supply. Escalation of compliance and product risks to EMEA Leadership Team and Senior Management Management review of Quality and Quality objectives established within Indivior and with key contractors. Maintaining current working knowledge of regulations that impact on role. MINIMUM QUALIFICATIONS: Bachelor of Science degree in a life science or engineering. Post- graduate and/or Professional Qualification related to Pharmaceutical or other related Quality Assurance skills is an advantage. Proven track record in the pharmaceutical, biopharma or biologics industries. Proven track record in a direct leadership role. Expertise managing geographically distributed teams. Expertise managing combinations of employees, contract workers, consultants, and external services organizations. Clear understanding and ability to assess and act upon product safety, quality, efficacy and compliance risks. A proven track record with experience working in a quality and or regulatory compliance function in Healthcare, Pharmaceutical, or Medical Device related industry. Solid understanding of finished drug product and drug substance regulatory requirements (e.g. EU GMP, WHO, PIC/S, CFR 21 Part 210/211, ICH Q7, Annex 1). Experience in hosting Competent Authority inspections and communicating with Competent Authority Inspectors and officials. Intermediate competency in sterile manufacture, proficient in Annex 1. Advanced competency in tablet manufacture, investigation and change control management, root cause analysis. Intermediate (advanced preferred) in PowerPoint and Excel Intermediate in Word, Outlook, Visio COMPETENCIES/CONDUCT: In addition to the minimum qualifications, the employee will demonstrate: Strong interpersonal and communication skills and ability to communicate clearly to all levels of the business, able to deliver concise written or oral summaries to senior management. Executive presence for giving presentations and updates is helpful. Influencing skills in areas with no direct reporting authority. Strong planning and organisation skills. Auditing skills, appropriate qualifications in auditing an advantage. Motivated by delivering high quality patient treatments in the arena of Addiction. Proficient in English. However, fluency in other languages is advantageous. Expected Travel- 20-40% (mainly to Ireland and France). BENEFITS: 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: 3 weeks’ vacation plus floating holidays and sick leave 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay 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 Gym, fitness facility and cell phone discounts GUIDING PRINCIPLES: Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. COMPLIANCE OBLIGATIONS: 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 behaviour. As part of your responsibilities, you are expected to: Employee Obligations: Always act with honesty and integrity. 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: Always act with honesty and integrity 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. 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. EQUAL EMPLOYMENT OPPORTUNITY EOE/Minorities/Females/Vet/Disabled