Mike Murphy Consulting Limited REGISTERED No: 8267700 ENGLAND & Wales REGISTERED OFFICE: 15 Warwick Road, Stratford upon Avon, Warwickshire CV37, 6YW

• Team Building

• Crisis Mgmt

• Process Design

• Execution

• Supply Chain Management

• Master Data • Launch Prepn

• Regulatory Compliance

• FSCA / Recall Execution

Risk Management Operations

Problem Solving

Change Management

Pharmaceuticals Medical Devices

!  Managed Hospira’s EMEA supply chain quality teams (49 FTE’s) for Pharma and Medical Device businesses.

!  Lead the quality organisation (175 FTE’s) for Janssen Pharmaceutica in Belgium, and aligned it with Operations to deliver customer needs, and sustain inspection readiness.

!  Prepared ProFibrix (MDCO) QMS for combination product launch - (MAA – BLA) x CE-marked class IIa delivery system. Refocused QMS from R&D-approval systems to commercialisation processes: change control, master data, production planning, complaints, product release, PQR .

!  Steered Verathon’s European MD team through labelling transition planning and associated changes received for EC-REP relocation

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!  Refined understanding and usage of root cause investigation techniques (KT / FTA / FMEA / 6M / 5 WHY) for critical deviations, and created WI structure to steer usage and capture outcomes at Patheon.

!  Ran workshops to gain consensus and support among diverse J&J stakeholders (RA, Medical Affairs, Healthcare Compliance, PV, Business groups) to transform a complex idea into a value-adding organisational entity.

!  Lead decision-making and implementation teams for major Durogesic recall situations for J&J, for example: 2004 – convinced licence holders and health authorities to agree staggered recall based on lot age to sustain market supply; 2005 – class I recall scenario that required 22-hour consensus-building to prepare go-live positions and documentation.

!  Lead and supported companies through successful implementation of several MD Field Safety Corrective Actions (FSCA’s).

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!  Trained Verathon Medical teams in SIPOC and Process Mapping techniques, and completed process maps for commercial, HR, technical services and quality / regulatory activities.

!  Project Manager for site FDA Readiness preparation at Patheon-France OSDF plant – PAI inspection successful.

!  Rebuilt Hospira’s regional HQ quality systems for UK and Netherlands teams to ISO13485 standards (distribution & vigilance) and steered QMS improvement for serialised device (infusion pump) service centres in EMEA.

!  Created and completed global Market Quality Manual (systems & processes) and gap assessment methodology to lead process improvement and operating performance within J&J Pharma globally.

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!  Deviations: completed independent retrospective assessment of site deviations as per FDA commitment (Mylan).

!  Recalls: concluded twin recalls of Class I medical devices in multiple EMEA markets for Verathon Medical (NL).

!  EU: (i) maintained fully satisfactory inspection record with Belgian MoH and overseas inspections from Korea, Brazil, China, and US-FDA, and (ii) managed risk-based audit program for BMS (substance & product).

!  FDA: (i) obtained approval for sterile operations in Janssen Pharmaceutica with zero 483 observations – 2005, (iii) supported multiple BMS site FDA-approvals for a variety of oral dosage form PAI’s, and (iv) sustained FDA approval for the BMS Ireland API facility in full compliance with 21.CFR.211 GMP - managed 3 successful FDA inspections.

!  Achieved successful major regulatory risk mitigation within Janssen by completing EMEA product remediation project (delisting, variation filing and product removal strategies – earned J&J Standard of Leadership award.

◦  Presented EFPIA position on 12/2008 “pharmaceutical package” at Munich PDA meeting (03/2009). Also served on the ICH Q8-Q9-Q10 implementation working group.

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!  Ph. D – Organic Chemistry / MBA ◦  Trained as Lead Auditor for ISO 13485 – BSI 2012. ◦  Completed QP Training Program (UK) via DBA - 2008

!  FDA Experience ◦  API Inspections - BMS (3) ◦  PAI Inspection support – BMS (5)

!  Liquid OS, tablet DC, tablet granulation ◦  PAI Steriles Inspection – Janssen

!  Line responsibility for Quality team !  Readiness project in tandem with commercial supply

◦  FDA Readiness – Project Manager for OSDF PAI in Patheon Bourgoin (F) ◦  FDA Medical Device (QSR) Inspection – CME (UK)Ltd

!  Project Management Experience ◦  Product Remediation JnJ – regulatory risk control ◦  Market Quality JnJ – end-to-end QMS systems design & execution; plant to patient ◦  FDA Readiness Patheon – first PAI for CMO’s French OSDF plant ◦  Deviations Review Mylan – independent assessment of process and contents (4y window) ◦  EC-REP Relocation Verathon – steered company through Label transition planning &

submission ◦  Master Data MDCO – designed and implemented processes for SME scale operations

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!  Freelance QA Consultant / Interim Manager – MD & Pharma: clients to date in UK, Poland, France, Netherlands and US.

!  HOSPIRA (Leamington - UK) - 2010-2012: EMEA Quality Director & Management Representative for Pharma (generic injectible hospital products & biosimilars) and Medical Device (infusion pumps and associated consumables) businesses - 16 Affiliate + 35 Distributor markets).

!  PATHEON (Swindon - UK) - 2010: Site Quality Director for QA, QC, QV and RA groups (c. 140 FTE) that support contract research & manufacturing at the sterile contract manufacturing operations facility in Swindon.

!  JANSSEN PHARMACEUTICA - J&J (Beerse - Belgium) ◦  2006-2009: Senior Director Market Quality within the Global Pharma Supply Group, with

responsibility for plant – to – market quality assurance worldwide. ◦  2003-2006: Senior Director Quality & Compliance with responsibility for QA, QC and QV groups

(175 FTE’s) supporting supply of liquid, semi-solid, pellet and parenteral products to >100 markets (165 formulae, 1,200 SKU’s, >115 MM packs p.a. - including narcotics - US $1bn sales).

!  PHARMACIA–PFIZER (Puurs - Belgium) - 2002-2003: QA Senior Director at Pharmacia-Pfizer, reporting to VP QA, with line responsibility for 6 FDA-approved drug product plants in Sweden, Italy, Belgium and UK.

!  BRISTOL-MYERS SQUIBB (Dublin - Ireland) ◦  1989-2002: International QA Director, with functional responsibility for drug product plants and c.

70 external manufacturers in EMEA, (and later) Asia-Pacific / Latin America. ◦  1983-1989: QC Manager, with responsibility for worldwide supply of API. ◦  1981-1983: Process Development Chemist – worked on Splenda process development; after 6

months, Chemical Process Manager for 24/7 manufacturing operations: labour, schedule adherence, facility management, product yield and quality.

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