Bryan Kelly

*** ********* ****

Madison, Wisconsin 53704

608-***-****

Email: ac6j3e@r.postjobfree.com

Objectives and Synopsis:

Seeking a technology related: Quality, Project or Business Management Position - Contract or Permanent

Consultant with over 20 years of success working as a Manager, Cross Functional Project Team Lead and Subject Matter Expert in Quality Management, Quality Compliance IT, MIS, ICT – operating within Science & Technology centered organizations.

Core skills in Computer System Validation (CSV) and Process Validation - aligned with both the FDA, ISO and ICH expectations. Excellent Quality Management Systems skills, aligned with 21 CFR, ISO and ICH requirements and directives.

Background with approaches and methodologies defined in GAMP 5. I am an expert with a risk-based approaches to CSV applying classic ‘V’ model strategies. Expert with requirements development and testing alignment. Skilled in documentation – objective evidence creation - aligned with IQ/OQ/PQ and associated testing results.

Excellent facilitator of technical dialogs, ideas and brainstorming sessions. I have completed numerous projects linked to point of service, big data, ERP deployments and governmental regulated data systems.

Project Management skills, skilled in taking user requirements from the ‘big picture’ to a level the IT professional can work against (Database Modelers, General Software Developers, Infrastructure Specialists, GUI Designers, and Usage Specialists etc.).

Good core IT skills set, certified by both Microsoft and Cisco as a Systems Engineer. Excellent skills with various formal requirements management tools (DOORS, HP Quality Center and other applications such as Enterprise Architect).

Advocate of pragmatic and integrated best practice schemes described by PMI's PMP, PRINCE2, CISS, ISO 27001 and ISPE’s GAMP 5 approaches.

Summary of postgraduate education and credentials:

Regulatory Affairs Certified - RAC US by the Regulatory Affairs Professionals Society

Certified Project Manager – PMP, PMBOK, PRINCE2, ITIL (ISO 20,000 including COBIT)

Certified IT Project Manager - ERP (Originally the Gartner Institute)

Certified Microsoft and Cisco Systems Engineer and Trainer - MCSE/MCT/CCNA/CCDA

Chartered Scientist (CSci) – The Science Council, United Kingdom

Fellow of the Royal Society of Chemistry (FRSC), London, England

FAA Pilot Certification – Unmanned Aircraft Systems – Certified to pilot unmanned aircraft systems up to 25 Kg – MTOW

Core Education:

BSc (Hons) Biochemistry & Physics, University of Lancaster, England • Business Studies, Northern Illinois University, US • Postgraduate Study, Computer Science, University of Oxford, England. Numerous vendors IT certifications – Microsoft, Cisco, Gartner and IBM.

Senior Consultant - Operating freelance as OTC Consulting Inc., 1997 to the Present:

EMPLOYMENT:

Current project:

Indian Pharmaceutical Organization – Consent Decree Remediation - Contracted in 2016 to Present.

Acting as a Project Manager and Subject Matter Expert for their Infrastructure Qualification and core SAP system.

This organization is on a ‘regulatory warning’ from the United States FDA for failure to comply with US legal requirements – my contributions have included institutionalizing aspects of Project Management from the Project Management Body of Knowledge (PMBOK), IT Security and Cyber Resilience - using CISSP domain knowledge, ISO 27001 guidance and Computer System Validation methods leveraging ISPE’s GAMP 5 approach, significant IT Security training roles.

Program Manager, Renal Care, US and Germany – Warning Letter Remediation

2014 -2016: Contract Program Manager for a large European renal care organization, operating ~2,500 renal dialysis clinics in the US. Hired to combine and create synergy between 23 separate and isolated projects under one PMO governance model.

Key role in managing 21 CFR Part 820 compliance for this large organization – ensuring alignment with ISO 13485/14971 and pertinent EU MDD regulations. Also worked with ICH guidance and the PIC/S Inspection Scheme.

The projects ranged from requirements management for software updates to dialyzer systems to engineering and operational redesigns of FDA regulated system that presented a significant risk to the health of the patient.

Worked closely with Nephrologists, Renal Care Nurses and Core System Engineers to integrate activities and on time deliverables.

Critical role in IT Security aspects of medical device firmware.

Quality Assurance Manager – Consulting Role – Medical Device Organization - Consent Decree Site – NDA in Place

2011 - 2014: IT based project redesigning a Medical Device Quality Management System based on DB2/UNIX, to meet modern expectations regarding electronic signatures and records in compliance with 21 CFR Part 11/Data Integrity and customer expectations. Worked closely with the marketing team in the US and EU on new product development leveraging stage gate methodologies designed around the accolade system.

Project Manager – Accuray/TomoTherapy – Medical Device Organization – Oncology Radiotherapy Organization

2009 - 2011: Project Manager with a focus on five major projects:

1. An offshore software development project working with RaySearch A.B. based in Stockholm. This product was designed for use in a clinical setting to optimize treatment regimens for cancer patients.

2. System upgrade to the TomoTherapy oncology treatment device – onboard diagnostic system.

3. Complete upgrade of supporting infrastructure for the treatment system.

4. Resolution of a hardware failure caused by a firmware error in the RAID storage system.

5. Key role in risk assessments relating to IT Security and Cyber Resilience of key firmware supporting core operations of these medical devices.

Interim Associate Director Quality – Cytochroma Inc.

2009 - 2010: Cytochroma was a pre-IPO organization with a focus on renal therapeutics. I was hired to ensure FDA compliance and to manage CMO and CRO vendor relationships.

Secondary role in the validation and verification area relating to internal data systems.

Consultant and System Architect – Paris, France.

2007 - 2009: Designed and worked with a LINUX (LAMP) based clinical data management system as a Project Manager and Subject Matter Expert. Key focus on 21 CFR Part 11 compliance and broader data integrity topics.

Translated all controlled documents from 'French' to 'Standard Business English' for FDA and customer consumption.

Based in Paris, Lyon and London, also supported business development activities in England.

Worked closely with Millennium Pharmaceuticals on the data processing of clinical data generated by Velcade clinical studies. Velcade was approved by FDA in 2008.

Medical Diagnostics - Quality Development Manager – Interim, Ghent, Belgium

2005 - 2006: Held a unique cross functional role, for the Innogenetics Corporation now part of FujiBio. Primary role was supporting the R&D Unit on the development of a clinical molecular diagnostic system for pathogen testing.

I also acted as the embedded software business analyst and validation specialist working with a software division of Carl Zeiss based in Munich. Worked with Zeiss to ensure embedded software would meet cyber resilience demands of several potential military customers.

Secondary role in developing cyber resilience strategies for this organization.

Computer System Validation Lead – Johnson & Johnson, Inverness, Scotland

2003 - 2005: FDA Mandated Computer System Validation activity working (CSV) with a large team of diverse stakeholders. My personal role focused on requirements management and compliance with FDA and ISO requirements. Worked with Oracle-JDE as an ERP and with Cisco and Intermec technologies. J&J Pharmaceuticals, Inverness, Scotland.

Worked closely with staff from Deloitte and Tata Consulting in India.

Business Analyst – Consulting Role

2003 - 2004: Clinical Study Process Mapping – Wyeth/Pfizer Pharmaceuticals. Focused on defining a clinical data management system that had grown in an ad hoc/organic fashion.

Mapped the ‘as is state’ and the ‘to be state’. The system was based on a telephonic approach to clinical data and had never been documented in a formal manner.

Worked with Clinical Studies Specialists, Cardiologists, and the core IT Development team to define a technology roadmap using ‘modern’ tools and technologies.

IT Systems Engineer – Various Roles.

1997 - 2003: Subcontractor for Microsoft Consulting Services and Practice & Operational Manager for a Microsoft Partner, numerous systems engineering roles, across a variety of industries ranging from insurance, printing/publication, medical care and agribusiness.

Permanent W-2 Roles

Quality Manager, AHPC/Viobin, 1994 – 1997: Active Pharmaceutical Ingredient Manufacturer (API), QC Laboratory Manager (staff of twelve) with other duties focusing on Process Development and Validation. Major support of Contract Research Activities, CAPA Resolution, Complaints Management, Methods Development/Validation, Process Development and Business Development via direct client technical interaction while acting as a Subject Matter Expert (SME) in Contract Manufacturing and Contract Research work.

Worked closely on Onconase with the Alfacell Corporation and numerous Oncologists – in the development of a potential new oncolytic agent.

Quality/Laboratory Manager, Gensia/Sicor – Teva Pharmaceuticals, 1991 – 1994: Managed a large laboratory group focusing on testing and release, technical staff of fifteen. I held a secondary role focusing on technology transfer, ANDA/NDA CMC support and direct FDA interaction with field inspectors.

Worked with the United Kingdom’s MHRA representatives in various capacities. Significant work with a potent oncolytics in a multi-use facility. MRP Validation and early adopter of GAMP thinking through GAMP SIG contributions.

This Biotechnology Corporation had two ‘flagship’ NDA products, Arbutamine and a Doutamine ‘System’ directed at the cardiology market. I worked closely with clinical study professionals including CABG Surgeons and Cardiologists.

QC and R&D Manager, Smith & Nephew Pharmaceutical, 1990 – 1991: Interim QC and R&D Manager for a company undergoing major organizational changes and challenges with major product recalls while under significant FDA scrutiny. Direct FDA interaction due to a failed release methodology due to historical weaknesses in the assay and systems validation thinking. Helped validate several manufacturing processes.

Quality/R&D/Laboratory Manager, Caremark Compounding Pharmacies/briefly a Baxter Division, 1988 – 1990: Managed a multi-use site included laboratories and distribution and a training center. Key focus was TPN antibiotic and oncolytic therapy compounding. QA program technical support including forensic technical analysis of customer complaints.

Secondary focus on custom development work driven by physicians and hospital groups served by Baxter.

Worked directly with several physician groups on Physician Sponsored NDAs. A key project was for a Cleveland based Anesthesiology Practice leveraging the Intermate, ambulatory infusion pump. Designed studies that would provide data for the Chemistry and Manufacturing Controls Section of the NDA.

Professional Education/Certifications and Awards:

Chartered Scientist – CSci.

The Science Council, Hodgkin Huxley House, 30 Farringdon Lane, London, England

2013

The Chartered Scientist (CSci) designation recognizes high levels of professionalism and competence in science. Established under the EU directive 2005/36/EC.

Evaluated work: Innovative implantable medical device designs intended to monitor various disease states leveraging bio-markers and wireless communication concepts, integrated into hospital informatics systems.

Fellow of the Royal Society of Chemistry - FRSC

Royal Society of Chemistry, Burlington House, London, England 2010

2010

FRSC is a senior category of association with the Royal Society of Chemistry. Fellow of the Royal Society of Chemistry (FRSC) is awarded by the Royal Society of Chemistry (RSC) in the United Kingdom. Eligibility for Fellow includes a requirement to have made an outstanding contribution to the advancement of the chemical sciences.

RSC evaluated work included: High performance polysuflone polymeric materials with a focus on ‘Extractables and Leachables’ issues in the Pharmaceutical, Medical Device, Bio-processing Industries and Hemodialysis Treatment Areas. An additional body of work was evaluated relating to trace level analysis of targeted extractable bioactive substances from medical devices and filtration systems and their toxicological implications on human health.

Publications:

Macroeconomics I and II written for The Edison School System and published in 2008 by Quantum Scientific Publishing/Sentient Enterprises – ISBN Numbers: 978-1-935119-32-6 & 978-1-935119-76-0.

Education:

BS (Hons) Biochemistry and Physics, Lancaster University, Lancashire, England.

Postgraduate Studies: The University of Oxford, England – Computer Science; Northern Illinois University, Illinois – Business Studies. MCSE, MCT (Microsoft) – CCN, CCDA (Cisco).

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