Job Description

TITLE:
Quality Manager, EMEA and Regional RP
Title: Quality Manager, EMEA and Regional RP
Reports To: Sr. Director Quality Operations EMEA & API Manufacturing
Location: Slough, UK
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 the chronic conditions and co-occurring disorders of OUD. Indivior is 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 a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.
POSITION SUMMARY:
Embedded in the EMEA Quality team, this position will provide oversight of Supply operations within the EMEA region, focusing on being a Business Partner to Supply Chain. This position will take ownership and responsibility for Discontinuation and Project Return activities as they relate to Supply Chain. This position will also include being named Responsible Person (RP) on the Indivior UK Wholesale Dealer Authorization (WDA) and in the Management of quality operations for Distributor Markets within the region. Manage and maintain control of key documents, data and processes that support the activities for the Global Commercial Supply Chain in EMEA, contributing where necessary; to vendor audit and evaluation activities (both remotely and on site) and more generally, ongoing vendor management activities, to deviations, to change controls and to product quality complaints. Provides direct support to resolve day to day product supply and supply chain related issues and leads key projects from an SME perspective, supporting product discontinuations and product launches into new markets.
Any available time not required to execute these responsibilities is to be utilized at the discretion of the VP, Global Quality or delegate.
ESSENTIAL FUNCTIONS:
The responsibilities of this job include, but are not limited to, the following:
Lead the Support of Discontinuation ProjectsSubutex Suboxone Tablets Temgesic Project Spruce Perseris

Lead the Support of the following ProjectsSupply of API to Ethypharm Project Return- Master Data, SKU evaluation and updates, BAU considerations, Process Mapping and Artwork Tracking

Named Responsible Person (RP) on the Indivior UK Wholesale Dealer Authorization (WDA)Execute the RP responsibilities as identified and as part of the Indivior UK WDA. Maintain appropriate oversight of UK operations to be in compliance with MHRA and EU Good Distribution Practices. Ensure the Indivior PQS is continually assessed to ensure that RP responsibilities and requirements are included in global and local quality systems and processes. Maintain Indivior licenses, inspection readiness requirements and personal continuing education to ensure the UK WDA is appropriately maintained.

Deviations & InvestigationsRaise deviations as necessary and lead the EMEA supply and distribution functions in investigations, root cause analysis and CAPA identification. Organise and compile relevant deviation documentation in electronic files. Liaise with external suppliers and internal functions to chase and close out CAPAs with supporting evidence for investigations. In conjunction with Global Logistics, review temperature excursions reports and support investigations, identifying appropriate CAPAs. Evaluate and produce Product Disposition Statements for batches /shipments subjected to temperature excursions.

Distributor MarketsEnsure distributor market partners are supported from a Quality perspective facilitating effective due diligence, qualification, and relationship maintenance throughout the product life cycle within each market. Maintain technical agreements with distributor partners and collaborate with the regulatory function where the distributor partner also acts as the Marketing Authorisation holder. Attend Distributor market business reviews with commercial business owners (global logistics) and provide quality oversight.

Change ControleQMS user, supporting Change Owners in EMEA and acting as change owner where necessary for Supply related projects and Supply Chain owned changes in the EMEA. Provide SME input and assessment to supply changes within the region and ensure quality actions associate with supply chains are made in a timely manner.

MINIMUM QUALIFICATIONS:
Education: Life Science degree ideally in Chemistry or Pharmaceutical science
Field of Study: Biology, Chemistry, Quality Assurance
Industry: Pharmaceutical
Experience: >10 years' experience working in a Healthcare or Pharmaceutical related IndustryWorking knowledge of EU and FDA Medicines legislation and good practices. Working knowledge of EU and EEA and Narcotic legislation and controls. Working knowledge of the Supply function, RP and QP legal duties. Comprehensive understanding of key pharmaceutical process needed for warehousing, distribution, and batch release. Detailed understanding of cGxP requirements e.g. GMP, GDP.

Computer Skills: Microsoft Professional, TW/Veeva QMS, Power Point
License/Certifications: Responsible Person (RP)
COMPETENCIES/CONDUCT:
In addition to the minimum qualifications, the employee will demonstrate:Good communication skills and able to debate and negotiate with personnel from all supply functions personnel Well-developed influencing skills Diplomatic and tactful in difficult situations Highly motivated and confident. Organised and able to deliver concise written or oral summaries to senior management. Able to lead on improvement plans within factory, requires a good manufacturing knowledge and an understanding of factory/quality management system. Persistent and driven to achieve a final solution. A completer finisher.

PREFERRED QUALIFICATIONS:
In addition to the minimum qualifications, the employee will demonstrate:Good organization and planning skills, previous project management preferred. Excellent communication skills, and negotiation skills. Good knowledge of Quality Management Systems and their application in the Pharmaceutical or similar industries. Knowledge and familiarity with the virtual Supply chain environment and of commercial product management through the supply chain. Strong working knowledge of European GDP Experience of working in a document control department within Healthcare, Pharmaceutical, or Medical Device related industry is an advantage. Experience within a Pharmacovigilance (PV) department or working with PV systems is an advantage. Experience in audit management and or vendor / supplier management programs is an advantage. Fully understanding of typical regulatory requirements relevant to a European regulated product e.g. EU GMP &GDP, and basic understanding of US regulations such as CFR 21 Part 210/211/820 and other market regulations.

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 includes25 days holiday plus public holidays Flexible working; core hours are 10am-3pm, and we offer up to 2 days working from home/ week for office based roles, as well as a flexible Friday programme, subject to completion of contractual hours. Paid Volunteer Time Off 10% company pension EAP service including Legal, Health and Wellbeing support Optional Health Insurance with BUPA Company Death in Service and Payment Protection Insurance 3 Celebratory days Access to platform for discounts on such as gym membership, shopping, holidays Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.

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:Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure 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:Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure 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