• People Manager of 9 team members in Clinical Supplies Quality (CSQ) Team which is responsible for the timely review and disposition of the clinical finished goods ensuring continuous supply of drug product • General managerial responsibilities for assigned staff including resourcing, training, people development, mentoring, goal setting, and performance monitoring• Ensuring appropriate handling of processes and systems in relation to receiving, manufacturing, testing and compliance of the investigational medicinal products with Swiss and EU Regulations, as of Clinical Trials Regulation (EU) No 536/2014 and GMP Guidelines• Acting as delegate on behalf of the Responsible Person: - Release of Clinical Finished Goods - Approval of transfers under quarantine requests - Providing RP concurrence for investigations and complaints on impacted clinical batches• Representing CSQ in internal and global meetings, and projects • Proactive communication and collaborations with functional areas to foster strong working relationship• Review and approval of SOPs, GMP Documents, Deviation and Change records• Supporting internal and Health Authority inspections• Release activities GMP and Regulatory Review of finished goods

Country Quality GxP Manager of ALPINE, CEE and BALTIC CountriesPosition Summary:Registered Responsible Person (Swiss QP / Fachtechnisch verantwortliche Person-FvP) according to Swiss Ordinance on Authorization of Pharmaceuticals, SR 812.212.1, Art 11/17 fulfil the technical responsibilities of the Swiss Establishment Licenses held by Alexion Pharma GmbH in compliance with Swiss Law. In addition, the Senior GxP Compliance Manager acts as the Quality lead for Austria and manages the distributor located in Slovenia covering the supplies in CEE, Baltics and Russia).Key responsibilities include:• Ensures that medicines are supplied according to Good Distribution Practices• Decides on the release or non-release of a batch for the Swiss market• Responsible for maintaining Quality Management System in accordance with Alexion’s Policies and local law• Front-facing person for internal and external inspection and ensures timely completion of initiated CAPAs• Management of the local Swiss Quality Management System including implementing, monitoring and maintaining the local QMS for all GxP, pharmaceutical and medical related activities for Switzerland• Setting-up and updating quality agreements (QAGs), in collaboration with Alexion Global QA, for delegated or subcontracted activities• Management of product quality complaints, quality defects and product recalls • Approving the disposition status of medicinal product returned from the Swiss market• Recording GMP/GDP deviation and Monitoring deviations relevant to the Swiss Establishment License• Management of Corrective and preventative actions (CAPAs) and change controls • Ensures oversight of local Swiss Distributor and acts the main contact point for any quality topic and participating in quality business review meetings, participating and approving local distributor qualifications and audits

• Registered Deputy of Responsible Person according to Swiss regulations • Ensure medicines, medical devices are supplied and traded according to Good Distribution Practices (GDP)• Approve for release (or reject) medicines, medical devices and returned goods for the Swiss market • Report Quality issues to Swissmedic according to requirements and within deadlines• Assist as required with the coordination of product recall procedures and compliance risks• Handle Quality issues with the responsible Warehouse/Supplier/Manufacturing Site• Preparation of Analysis of KPIs (Key Performance Indicator) and presenting to the Management • Process Quality complaints received from customers and direct action to reduce the risk of recurrence incl. reporting into Global Complaint Reporting System (TrackWise)• Contact person for all Quality issues for AbbVie AG for Swissmedic, the Cantonal Health Authority and Third Party Manufactures• Maintaining the Quality Management System in accordance with Swiss pharmaceutical law and AbbVie policies• Cross functional collaboration with internal and global stakeholders • Provide training in GxP elements and procedures, create awareness and coordinates solutions by referring to the appropriate people to get resolution• Supports RP in in qualification of new and current suppliers and 3PLs and in ensuring that all business is conducted in accordance with the Swiss law on Medicinal Products• Assist RP in preparation of audit agenda, audit reports summarizing quality problems with internal GMP audit and ensure timely completion of defined CAPAs

QA systems & programs: • Development and implementation of internal company regulations in the field of material, rejection, recertification • Development / maintenance of systems to ensure that manufacturing, packaging, analysis, storage and distribution / shipping by the company's internal, regulatory and guidelines according to state of technology • Development and improvement in manufacturing respectively product-related clinical deviations • Review and approval of clinical OOS / OOT investigations Responsibilities in the area of active material production as Deputy for the RP (Responsible Person / QP in Switzerland):• Preparation of commercial and clinical release dossier • Release of master documents and batch documentation• Release / rejection / recall of raw materials, master and working cell banks , active substances• Support of rejection / recall of drug substance QA responsibilities for Bulk Biologics as Deputy for the RP (responsible person) checking approval of: • GMP relevant regulations and guidelines in the field of manufacture and release • Batch documentation, conduct of clinical recertifications• Permission of risk use of non-approved clinical material• Permission of Quarantine Shipments of non-approved, clinical materialSpecial tasks: • Support for QA release the drug substance • Implementation of the SOP review and approvals • Representation of Quality WAG in different project teams as IDST / DSP• Representation QA WAG in harmonization projects • Review and approval of clinical and commercial specifications for API and Drug Product on behalf of QA Manager QA responsibility for equipment qualification and validation computer sytems: • Review and approval of qualification / SDLC documents and approval of equipment / systemsaudit exposure to regulatory agencies (FDA, Swissmedic)• Gap Analysis for PAI Readiness

 for commercial production• Conduction of internal audits

• Coordination and monitoring of all activities within the global clinical studies department with respect to conduct of clinical studies• Coordination of all activities referring to use of comparative products for the clinical studies• Preparing and monitoring the activities of external suppliers • Development of proposals for the optimal preparation of primary and secondary packaging of clinical studies• Process development for the packing and shipping of clinical studies in collaboration with the planning group in the mother house in the USA• Creation and maintenance of a complete GDP documentation for all processes for clinical studies; and also responsible for the maintenance of the corresponding databases• Monitoring of logistics in respect of all materials used for the packing and shipping in clinical studies• Creation and forwarding of various reports such as project-related reports for group meetings • Participation in task forces for optimization of processes and create appropriate SOPs and global guidelines