1. Josephine O'Reilly
BSc (Hons) MSc,PhD, HDip, MBA.
Head of Quality EMEA at UCB
Avenue des Chasseurs 15, Waterloo, Brabant Wallon 1410 Belgium
Phone: 0032 497591040
Web Profile: be.linkedin.com/Josephine o reilly
E-Mail: joo_reilly@hotmail.com
Summary
• Pragmatic and passionateQuality Assurance Executive with extensive experience (20+ years) working in
the pharmaceutical and biopharma,medical deviceand diagnostics industries - in Commercial Production,
Research and Development environments.
• A sound business acumen and fiscal understandingand haveheld senior positionsin major pharma
organizations as theindividual responsibleand accountablefor sitecGMP quality and compliance.
• Culturally-awareand sensitive,lived and worked in North America and in Europe, and have travelled
worldwide for business and auditingactivities.
• Expertise in GMP (21CFR820,QSR, 210,211) and other international Quality standards,ISO,EU GMP,
JPAL, CMDR and WHO regulations,and ICH standards.
• A respected Quality and GMP QA professional who has a comprehensive understandingof the quality
and batch certification requirements for the releaseof many types of products that includeboth sterile
and non-sterilepharmaceutical products,controlled drugs,biotech,a pre-filled syringes,solid and
liquids,and semi-solid forms ,patches, medical devices and diagnostics.
• A competent and confident communicator and skilled in developingand presenting tailored training
courses on drug development, quality assuranceand the recognised Good Regulated Practices - i.e. the
GLPs, GMPs, and the GDPs.
• Have expertise in the instigation of SOP systems and QMS within pharmaceutical and medical device
companies to ensure regulatory complianceand to ensure systems also operate efficiently for the
business.
• Experienced of managingan electronic QMS to current pharmaceutical standards and in compliancewith
21CFR11 and the GAMP regulations,acrossmultiplesites in USA/Europe/Asia-Pacific.
• Conversant with the USA and EU GMP regulatory requirements for the manufacture, supply and testingof
investigational medicinal products for clinical trials,and havecomprehensive understandingof the ICH GCP
regulations for clinical studies.
• A trained pharmaceutical GMP auditor (David Begg Associates & RSSL). Played key roles (includingas
QA host) in Regulatory Audits (UK MCA/MHRA & US FDA pre-approval inspection,Health Canada,
EMA), which were highly successful for these companies (zero FD483s /nil major GMP deficiencies).
• A confident and proficientmanager of projects and people (managed teams of up to 60 people).
Highly motivated to ensure the successful implementation and completion of project tasks on time
and to a high standard. Focused on the tasks in hand,a positive“can-do” attitude.
• Computer-literate, possess strongcommunication and interpersonal skills.An authoritativeand a credible
leader / professional who believes in gainingthe trust and respect of colleagues and leadingby example.
• Lead and give direction with vision and ability to promulgate and implement transformational change
programmes across global teams

2. Employment Experience
Head of Quality EMEA and APAC at UCB
March 2015 - Present
 Member of Regional Quality and Safety Leadership Team
 Lead Change management initiativeto Regionalized QA, RA and PV from a local function to a global function
 Manage and develop a global quality management system and global quality standards.
 Responsiblefor overall quality of drug products includingreleasefor distribution in theEU (EU Directive
2001/83/EC) 7 QPs and 7 RPs across Europe.
 Responsibleto manage and oversee of the Quality Assuranceactivities within EUAffiliateand outsourced
manufacturingsites to ensure in compliancewith regulatory and global corporaterequirements.
 Responsiblefor trainingmatters to QA members and responsiblefor cross functional teams.
 Responsiblefor organizingand executing audits of manufacturing sites, CMOs - 3rd party suppliers, suppliers of
critical materials – API’s.
 Member of corporate Global Risk Assessmentteam to perform onsiteinspections periodically worldwide.
 Involvement in preparation of sites for regulatory inspections.
 Responsible to develop local procedures and assist with Global Quality Systems with the legislation updates
impact and implementation of required updates to global systems.
 To develop and maintain AffiliateQuality Management Systems for continuous improvements.
 Member of the technical and recall committee
 To assesscurrentand developing regulations and regulatory position in order to develop and implement
changes within the business to ensure continued compliance.Audit, Regulatory Standards,Project plans and
milestones.
 Responsibleto providesupport to regulatory and complianceteams on variations on existingproducts and new
product submissions
Director of Product Quality at UCB Pharma
March 2012 - March 2015 (3 years)
 Reorganization of QA division to ensure ProductQuality Management of a major product
 Define strategy and Vision for future quality departments and associated products
 Operational management and process development and streamlining to support organization
 Covers the entire product lifecyclefrom initial commercialisation includingTechnology Transfer/Knowledge
transfer,commercial (key rawmaterials to distribution),productimprovements to phase out
 Support preparation and execution of product launches from QA perspective (e.g. launch strategy, align QA
activities,submission review,attend launch team meetings, etc…)
 Review and providerecommendation for product Strategy
 Work closely with CorporateQA teams, Technical Operation Teams, Business stakeholders and Affiliates in an
effective and efficientway
 ProvideQA supportfor all commercial initiatives and commercial activities atthe TST
 Responsiblefor the routine LifeCycle Product Management activities,ensures that all Lifecycleprojects are
supported
 Provideexpert QA advice,support and management for technical operational QAand general QA matters for
the supply chain for the product. Specifically productoversight, Product Disposition,Regulatory support,
coordinatingrecallsand technical meetings
 Work closely with staff in the Corporate QA teams (especially CMC Clinical Supply QA,Corporate Compliance
and AffiliateQuality Services) and key Technical Operations teams/Affiliateteams to ensure that all QAservices
for the Product areprovided in an effective and efficient way.
 Establish key performance indicators (metrics) for key operational QAactivities and services associated with the
Product vendor supply chain and projects.

3. Director QA Commercial Small Molecule products at UCB Pharma
October 2011 - March 2013 (1 year 6 months)
 Responsibleand accountablefor a team who managed all strategic CMOs and suppliersof key or with external
partners (as contractgiver or contract receiver) responsibleto
 Manage all aspects of the supplier management system, includingreviewand approval of supplier requests,
performing supplier risk assessments,ensuringQuality Agreements are in placeand maintained,maintenance
of the approved supplier list,and performingsupplier evaluationsas per requirements.
 Manage the follow-up of supplier auditreports and where required, ensuringadequate correctiveand
preventative actions arein place.
 Ensure all operations arein compliancewith ISO13485,ISO9001,and GMP regulations.
 Review and approval of Standard OperatingProcedures,Change Requests, and technical reports.
 Review and trending of deviation and non-conformity data,ensuringroot causeand CAPA activities are
identified.
 Performing of qualification / validation activities on manufacturing equipment.
 Supporting the business quality system by monitoring and reporting on supplier related metrics.
 Contribute to the development of and maintenance of the quality management system.
AD Analytical Centre of Expertise at UCB Pharma
July 2010 - September 2011 (1 year 3 months)
 Define strategy, Establish,steward and harmonize all essential corporateanalytical processes atUCB sites and
contractmanufacturer for Biological and chemical drugs globally:
 Establishmentof worldwideanalytical strategy for UCB
- Implementation of a new QC organization (chemical and Bioassay) with successful FDAaudit
- Analytical Processes:Method Development, Validation,Transfers,New Technologies
- Establishmentof worldwide analytical strategy for UCB, includingoffshoring
- Streamline and harmonize global analytical processes through the creation of a Center of Excellence
- In depth Regulation awareness for EU, US, Asia
 Lead the Corporate Analytical Sciences function with a global scopeon Commercial Products (from Ph. III to the
end of the lifecycle),Processes and Systems in Analytical Sciences & Quality Control Testingfor UCB
 Long term plans,strategy and needs in the analytical field for UCB
Associate Director QA Vendor and Project Manager at UCB Pharma
February 2010 - July 2010 (6 months)
 Manage the follow-up of supplier auditreports and where required, ensuringadequate correctiveand
preventative actions arein place for Biological Product.
 Manage all aspects of the suppliers,includingreviewand approval of supplier requests,performing supplier
risk assessments,ensuringQuality Agreements are in placeand maintained,maintenance of the approved
supplier list,and performingsupplier evaluationsas per requirements.
 Ensure all operations arein compliancewith ISO13485,ISO9001,and GMP regulations..
 Review and trending of deviation and non-conformity data,ensuringroot causeand CAPA activities are
identified.
 Performing of qualification / validation activities on manufacturing equipment.
 Supporting the business quality system by monitoring and reporting on supplier related metrics.
 Contribute to the development of and maintenance of the quality management system.

4. Associate Director Project and Portfolio Management CMC at UCB Pharma
February 2008 - February 2010 (2 years 1 month)
 Define strategy, establish,build,steward and harmonizeall the establishmentof CMC Plans and portfolios to
facilitatethe development of new Biological and chemical drugs fromdevelopment through to Launch and
Phase4
 New Strategy and operating model definition and deployment (2014) with new CEO (definition,
communication,engagement and appropriation,behaviors and strategic priorities)
• Innovation process design to leverage in house competencies beyond the job
• Exploreand launch new ways of working beyond current organizational models
 Drive strategic plan definition (5-10 years) and execution
• Manage efficiency programs and activity based budgeting
• Executive Committee strategy definition and cross functional implementation,KPI definition,monitoringand
dash boardingto supportstrategic decision making
• Lead company-wide cross functional processimprovements (executive committee decision makingprocess,
purchasing/sourceto pay, HR processes)
 Project Manager for change management programs and education or trainingto operational excellence
(Kaizen, Six Sigma, Lean, …)
• Lead for global cross functional process improvement projects
 Buildingthe organization in chargeof global clinical supply chain fromdesign to production and distribution.
• In charge of the outsourcingof clinical supply chain activities
Quality group leader at Vistakon
2006 - 2008 (2 years)
 Total administration of QC department includingrecruitmentof manpower, equipment purchasing,etc.
 Annual Staff appraisals.
 Ensures laboratory complianceand performs productrelease trend analysis.
 Ensures planning,production and testing systems, and prioriti zeprojects for the continuous improvement of
systems, methods and processes,consistentwith Company quality standards.
 Prepares budgetary projections for manpower, capital equipment, Develop annual plans,budgets and
objectives that meet the business need for continuous significantimprovement in performance of the business
area.Manage plans and budgets. Prepare costbenefits analysisof projects and present for approval.
 Effectively working with others in Manufacturing,Commercial,R&D and external customers, collaboratorsand
suppliers to ensure that established and new products meet planned availability dates and conform to the
agreed specificationsand customer expectations.
 Reviews and ensures the reliability of technical data related to Analytical documentation likeValidation
Reports, Stability Data,Micro reports,Dissolution Profiles,Impurity Profiling,SOPs,Calibration reports,etc.
 Communicates effectively to Executive management regardingprojects planning,status,and company issues.
 Technology transfer of new products developed by R&D to Finished products group.
 Preparation and execution of IQ, OQ, PQ protocols
 Preparation,followup and supervisingof Internal / External US- FDA, MHRA, TGA, MCC, WHO and third party
audits..
 Maintains a highly functional organization by planningand implementingtrainingin areas such as safety,
computer technology, New Analytical Techniques,equipment and processes,project planning,time
management and communications.
 Doubled the output of the lab without changingheadcount requirements usinglean 6 sigma

5. Project Manager at Abbott Diagnostics
2004 - 2006 (2 years)
 Responsiblefor the transfer of Diagnostics immunoassay products fromthe USA siteto Irish site.
 Project management of startup of Operations for brand new facility atAIDD (Abbott Ireland Diagnostic
Division,Longford,Co. Longford).
 Transfer of production from ADD (Abbott Diagnostic Division,LakeCounty, Chicago,USA) to AIDD (Abbott
Ireland Diagnostic Division,Longford, Co. Longford).
 Transfer of three diagnostic products fromthe US to the new facility in Longford.
 Establishmentof Transfer Sub-Plan and Timeline by workingcollaboratively with the cross-functional team.
 Ensured that activities were executed in compliancewith Sub-Plan and Timeline.
 Update of transfer timeline on a continuous basis to monitor progress and highlightany constraints thatwere
encountered.
 Development of contingency plans and presentation to senior management.
 Generation of Transfer History Files thatwere in compliancewith quality requirements.
Ensured regulatory and compliancerequirements were met for the transfers.
Principle Scientist at EvanesCo
2002 - 2004 (2 years)
• Responsibleto Obtain venture capital fundingfor EvanesCo by establish lab and developingtechnology to
prototype. Sold for 10 M 2014
Formulation Chemist at Syngenta
May 2002 - November 2002 (7 months)
• Development of life-cycleextension formulations of leadingagrochemical.
Post Doc Fellow at Therics Princeton, US
2001 - 2002 (1 year)
• Establish,develop and manage cell cultureresearch facility to support ongoingmanufacturingand clinical
trials under GMP and GLP conditions for 510K submissions for 3D printing technology usingMinerals
Academic Experience
EMBA Candidate at Vlerick Business School
January 2015 – June 2016
NSFDBA: ICRS Pharmaceutical Auditor Training
May 2014
University of Reading and NSF DBA York
QP training, 2010 – 2011
•Active Pharmaceutical Ingredients
•Analysis and Testing
•Biotechnology Issues
•Formulation and Processing(Part1)
•Formulation and Processing(Part2)
•Investigational Medicinal Products
•Law and Administration
•Mathematics and Statistics

6. •Medicinal Chemistry and Therapeutics
•Pharmaceutical Microbiology
•Pharmaceutical Packaging
•Pharmaceutical Quality Systems
•Roles and Professional Duties
SQT training Ireland: 2008-2009
Quality Management Systems Auditor / Lead Auditor (ISO 9001)
14385 Medical deviceQuality Management Auditor
Prince 2 Certification: 2008
Black Belt 6 Sigma and Lean: in house to UCB: 2008
Chambers Ireland and DCU
Higher Diploma in Innovation Management, Management, 2006 - 2007
University of Nottingham School of Pharmacy
PhD, Pharmaceutical Science,1998 - 2001
University College Dublin
MSc, Biochemistry and Mechanical Engineering 1996 - 1998
University College Dublin
BSc, Chemistry and biochemistry,1992 – 1996
Eureka Secondary School, Kells
Leaving certificate,general, 1986 – 1992
Languages:
English:French, Irish
Member of Professional Bodies:
Royal Society of Chemistry
Royal Society of Biochemistry