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.

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 Industry

• Working 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)

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.

The responsibilities of this job include, but are not limited to, the following:

Lead the Support of Discontinuation Projects

• Subutex
• Suboxone Tablets
• Temgesic
• Project Spruce
• Perseris

Lead the Support of the following Projects

• Supply 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 & Investigations

• Raise 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 Markets

• Ensure 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 Control

• eQMS 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.