Summary:

(CSV) Validation, commissioning, qualification, software program development

** *****’ experience in the Clinical, Pharmaceutical, Bio-tech, Medical Device, Food and IT industries.

Strong ability to effectively communicate across all organizational levels to achieve program outcomes.

Broad industry perspective and a clear understanding of processes, methodologies, and tools.

Engage large or small initiatives with regulatory driven approaches, methodologies and processes

Skills:

Software plays a significant part in a product's lifecycle but is the most misunderstood. My job is to create a software management strategy that monitors and maintains company software assets throughout their lifecycle. I am a regulatory expert who develops program-level policies, procedures, templates, and processes for managing thousands of software applications, hardware, data, and records. Management includes creating a strategy for validating, qualifying, and commissioning simple systems in one month.

I replaced technology group members with new software processes, saving the company over 1 million dollars in salaries and millions in new contracts. I am a quality QA-IT/CSV software regulatory expert who understands your technical and business requirements. I want to build your software compliance program. I create your policies, SOPs, and templates for planning, commissioning, qualifying, validating, calibrating, monitoring, automating, and maintaining all company software program assets. I want to ensure that all software assets are uniquely integrated into your company's goals.

Author:

“US and EU Cloud Computing Policy and Acceptance” – ISBN: 978-0-9985040-1-8

“Information Stored in Cloud and Computer Systems” – ISBN: 978-0-9985040-2-5

Education/ Certification/ Training:

Masters in Quality Assurance/Regulatory Affairs – Computer Systems Temple University 2003

Graduate from the school of Pharmacy 2003

Masters in Theology Liberty University, Lynchburg, Virginia 2010

Drug Development Temple University 2002

BA Chemistry Temple University

Background

Comprehensive Commissioning and Qualification, Validation/Remediation Plans, CSV, IQ/OQ/PQ,

Risk Management: compliance risk, data flow and assessment, business assessment

Project Management: Clear vision, Strong team building skills, Creating the environment/tone

GRC/ Quality Assurance/Regulatory Affairs directive especially in, Quality Management/System initiatives in Training, Change Management, Audits, Inspections, CAPA, Risk Management, Document Control, Product

EXPERIENCE:

Piramal Pharmaceuticals (Teva supplier) – Pennsylvania

Validation and Software Program Development 05-2023 to 10-23

I built the CSV program at Piramal. I designed, developed and approved all program level policies, procedures and processes. Activities included developing 30 CSV program-level procedures and validating/commissioning a simple system in one month. We just laid off ten technology group members and replaced their activities saving the company over 1 million dollars in salaries alone! I am a quality expert who understands your integration requirements.

Validated Quality Systems (Cannabis- Food)

Ecommerce/Affiliate Management Program Development 02-2023 to 05-2023

Built an “E-commerce” and "Affiliate Management" program for www.Torpedopot.com and www.Cana-pot.com. I conceptualized and managed all project initiatives. I developed project schedules, procedures, policies, and manuals for the users, administration, and affiliates. I worked with development, finance, marketing, administration, regulatory, and third-party software solutions. I collaborated with Legal to develop the contracts and agreements. We used PayPal for disbursements. The website is fully automated. The affiliate program backend is designed to register affiliates and send out legal contracts automatically. We eliminated the need for oversight. The programs are hosted on Godaddy's platform. I provided training for project personnel. We have over 100,000 monthly views and integrated thousands of videos into the user's experience.

Piramal Pharmaceuticals (Teva supplier) - Pennsylvania

QAIT Architect 07-2022 to 02-2023

In less than six months, I built a new, highly efficient risk-based CSV program in preparation for an FDA audit and product release. I Developed twenty-seven new CSV program local procedures and seamlessly integrated them into the Global Information Technology group. I assigned roles, and trained personnel to support the program. Once complete, I used the program to validate laboratory systems and IT applications. The program is a risk-based initiative that manages hardware, software, and Quality Systems, for all GAMP categories. I authored ERES, Data Integrity, and Audit Trail procedures. It passed the FDA audit with no findings. I also managed Change Controls, Deviations, CAPA and other base business processes. Validation of new interfaces for LIMS. Moving data from third party into LIMS and creating new fields.

Abbott Laboratories Quality Assurance -

Non-Product Software (NPS) Validation 09-2020 to 05-2022

Help build the Non-Product Software Validation group with a focus on software and spreadsheet validation for laboratory equipment. I am responsible for creating, managing, and supporting Abbott's software validation projects. I managed system changes in Agile. My main goal was to create an efficient software validation process that's aligned with QA, IT, Change Control, Business Owners, and various stakeholders.

Phillips Medical – Germany 05-2019 to 09-2020

Medical Device/CSV SME

Participate in all CSV related projects within the MA&TC scope in support of achieving company objectives and Philips ongoing commitment to close out consent decree findings. Act as a SME and lead CSV initiatives as assigned; perform activities to ensure CSV activities are performed, scheduled, planned, resourced and completed in accordance to established timelines. Work closely with other Q&R members, IT personnel, system business owners, end users, etc. to provide adequate support and expertise; communicate effectively and clearly throughout all levels of the organization. Guide stakeholders on software validation/quality relevance to establish suitable validation requirements and deliverables in accordance with FDA regulations, GAMP 5 principles, and global policies and procedures.

Black Diamond Networks @ ProMetic – Canada 09-2018 to 03-2019

IT/CSV SME

Work with the VP of Quality and Production towards implementing CSV program for integrating Syspro ERP system on the Azure Cloud. My involvement includes but not limited to establishing roles and responsibilities, including approving, reviewing, and authoring CSV procedures, templates, change controls, risk assessments, validation, training, deviation reports and more. I developed a validation methodology inclusive of creating all project documentation for building a System Development lifecycle for software development and system implementation.

Black Diamond Networks @ Regeneron Pharmaceuticals Inc. Pharmaceuticals:

Albany NY 12-2017 to 09-2018

Sr. IT Automation Investigator

Perform investigation of manufacturing anomalies related to automation hardware and software. Investigate environmental monitoring systems. Manage projects related to design, commissioning, and performance improvement of automated systems. Incorporate Root Cause Analysis methodology for NCRs and provide guidance to cross-functional teams to ensure software quality objectives are met for product and non-product software. Contribute to risk management, software risk analysis, hazard analysis, and failure analysis.

GSK Pharmaceuticals:

Philadelphia 07-2016 to 11-2017

GRC Lead for North American Applications

Develop a risk-based approach and methodology for managing project and approving (risk assessments, Defects, change control, training, project/program deliverables and document lifecycle for 70 applications (third-party programs, media, websites, mobile, eMail, social media) replaced by SAP, across the US, Canada, and PR. The effort was on HCP healthcare companies and DTC medication, test kits, or medical devices. This includes activities for digital marketing integration and external partners and capability leads to develop innovative new processes.

Applications for 91 markets were assessed for compliance against EU and FDA regulations, guidance and internal processes for seven north American business process areas,

Purchase to Pay – requisitions, purchase orders, receipt, invoice, accounts payable and payments

Record to Report –accounting, taxation, treasury processes, and financial and management reporting

Order to Cash – sales entry and processing, accounts receivable, customer queries and complaints

Forecasting – business planning, sales, marketing, finance, supply chain and demand planning

Supply Chain Planning – inventory levels for commercial inventory locations including ‘factory-facing’ main warehouses, local, regional depots, and distributors’ stocks

Warehouse and Distribution – management stock, goods receipt and storage, general management of inventory, and shipping activities including traceability in accordance with Drug Supply Chain Security Act (DSCSA).

Trade Spend Management – trade promotions and agreements covering the creation, evaluation, approval, accrual, payment, closure and review of these discounts and rebates.

Shire Pharmaceuticals:

Waltham Connecticut 12-2015 to 06-2016

CSV Led for a Global Implementation ITSM (SME CSV Software Consultant – SAAS)

Responsible for managing CSV efforts for a team of analysts, developers, testers and engineers to drive delivery of (ITSM) SIAM (Service Integration & Management Delivery) GXP processes for Change, Event, Problem, Incident, Configuration, Deployment, Release, Validation and Testing, etc. Twenty-one IT service Management process areas were integrated into seventeen functional business units. I served as a CSV specialist with expertise across all tracks. Responsible for document approval, review, records management and records storage. I developed methodology, approach, and templates for executing Risk Assessment, V-plan, Infrastructure Qualification, Testing, and Data Migration utilizing as well as traceability, training and document control via Quality Center and Master Control.

Church & Dwight: Reading PA 08-2015 to 10-2015

Sr. QA lead for Vitamins, Minerals and Supplements

Work on special projects for a New Startup: Manage CAPA generation and implementation for facilities utilities and equipment. Work with the plant management to whip new processes into place, redefine batch reports and Investigate discrepancies, etc. Report to the Director of Quality. Authored SOPs for the PM and operation of steam system and new equipment/parts for various facilities.

Astellas Biotechnology: Oklahoma 05-2015 to 08-2015

Sr. Project Manager for Cleaning Validation

validated serialization equipment Utilized sterile swabbing The swabs are rubbed over the test surface to determine the type of microorganisms on the swab by subculturing it to media I authored validation protocols, Studies, and procedures as well as trained and walked personnel through the process, conducted Risk Assessments, determined cleaning agents, defined automated vs manual cleaning, managed operators and technicians wrote communications, released equipment, determined hold times (dirty/clean/sanitized), and conduct various studies on the ability of the environment to keep equipment clean, collected swabs and determine sampling locations for TOC and detergent residues for equipment like the Korsch, Tarceva, Fetti and Courty press, Bohle, etc.

Paragon/Celegene Pharmaceuticals Bridgewater NJ April 2015 to 1 Month Duration

Quality System Expert

Developed a set of Global Quality analytics (Metrics, KPI's, Dashboards, Scorecards, Wireframes) for the CAPA and Deviation process to be included in the APR. Structured workshop activities and responded to the RFP's

DepuySynthes (Medical Device Prosthetics Warning Letter) West Chester PA July 2014 to January 2015

(SME) for Production and Process Controls

PMO SME Manager for Utilities, facilities and Equipment.

Demonstrate clean room performance and controlled product bioburden with monitoring the environmental conditions in their aseptic manufacturing areas.

Developed and executed assessments for European and U.S.A manufacturing sites for compressed gas and preventive maintenance program.

Executed ISO assessments for Controlled Environment Areas CERs and Clean Rooms (Compressed Gas, HVAC, Environmental Monitoring, PMs, Hydrocarbons, Training, Procedures, Vendor Management, etc .

Performed Audit Remediation and CAPA root cause and corrective / preventive action as necessary. Performed CAPA verification of effectiveness as necessary.

Held daily meetings and travel to Legacy Synthes sites and provide assessments.

Provided consultancy and guidance related to Facilities and Equipment Controls and Legacy System.

McNeil Pharmaceuticals Consent Decree -Lancaster PA April 2014 to July 2014

(SME) Cleaning Validation

validated serialization equipment Wrote and managed execution of cleaning validation, protocols, analyzed microbiological, visual, analytical and physical data to detect trends and develop corrective actions as necessary.

Wrote validation reports to summarize results and findings.

Reviewed and analyzed cleaning run records, detected negative trends and non-conformances, and developed and implemented process improvements as needed.

McNeil Pharmaceuticals Consent Decree Lancaster PA January 2014 to April 2014

QA oversight of protocol and Batch Records for Cleaning and Packaging validation

Mentored and provided guidance for QA manufacturing batch record documentation for accuracy, completeness and compliance with effective SOPs to ensure the strength, identity, safety, purity and quality of the product.

Completed walk downs to ensure adherence to GXPs.

McNeil Pharmaceuticals Consent Decree -Lancaster PA September 2013 to January 2014

(SME) CSV Subject Matter Expert

Developed the methodology and procedures for CSV system use / operation, data backup and restore periodic review, change management, problem reporting, archive and retrieval, performance monitoring, preventive maintenance, startup and shutdown, configuration management, records retention, security/system administration, and business continuity for manufacturing and laboratory systems.

McNeil Pharmaceuticals Consent Decree -Lancaster PA June 2012 to September 2013

Sr. QA CD GMP Specialist

Worked with quality work stream leads. Participated in FDA audits, investigations and walk downs (ETQ and TrackWise). Ensure that documents and records are appropriately created, captured, accessed, managed and stored in a manner that reflects business, corporate and regulatory compliance requirements.

Facilities/utilities/Equipment (Compressed Gases, HVAC, Pest Control, Purified Water System, Calibration, Commissioning and Qualification, Cleaning & Sanitization, Maintenance, Security Controls, Infrastructure).

Validation (Computerized system Validation CSV, Cleaning validation, product, Process, CSV/electronic records-electronic signature processes, GMP Spreadsheet Remediation, Computer Systems and Applications, Packaging, Process validation, Laboratory systems, Manufacturing systems, etc).

Verizon / Terremark: Pharmaceutical Cloud Systems -North Carolina September 2012 to December 2012

IT GMP Cloud Expert

Audited Verizon server farm to determine if the system can be used to manage information, by integrating 21 CFR part 11, 820 Quality System, and ICH Quality Management and more. I provided executives insight into applications used in the Pharmaceutical, Medical Device, Biopharmaceuticals sectors.

Hospira: Pharmaceutical and Medical Device -Oklahoma January 2012 to May 2012

Project Manager Senior Clinical Investigator

Managed a team of six investigators at Hospira to write Quality Investigations for deviations on the client's Quality System in TrackWise.

Shin Nippon Biomedical Laboratories (CRO) Seattle July 2011 to January 2012

Senior Project Manager IT/ QA Clinical Validation

Managed remediation effort CSV in Toxicology, Carcinogenicity, Developmental & Reproductive Toxicology Immunotoxicology, etc.

Loma Linda University- Africa May 2011 to June 2011

Sr. Auditor for Pan-African Academy of Christian Surgeons (PAACS)

Audited four hospitals in Eastern Africa for clinical and operational compliance: Sodo Hospital (Ethiopia), Kijabe Hospital (Kenya), MCM Hospital (Kenya), Tenwek Hospital (Kenya).

Lannett Pharmaceuticals-Pennsylvania March 2011 to May 2011

Project Manager

Reported to the CIO Develop Process Maps, Narratives and Efficiencies for an SAP implementation into their Quality System, specifically the manufacturing process.

Novartis/Ciba North Carolina October 2010 to March 2011

Sr. Validation Manufacturing Execution System (MES) WonderWare

Contact Lens manufacturing Upgrade of the MES system to become compliant with the most recent Novartis standards (Windows Server 2003 SP2 and Oracle 10g) and address compliance gaps.

Moved equipment and processes to India.

Accenture: (PGMIT) PFIZER -Collegeville March 2010 to June 2010

Clinical System Project Manager

Managed 16 resources on/offshore resources Manage cost, schedule, and performance of component projects for the Wyeth/Pfizer merger for merging post marketing commitments (PMC), (CMC) commitments, mutual recognition program (MRP), EU centralized approval process (CAP), de-centralized (DCP), nationals (specific to a board of health), investigational new drug annual reports (INDAR) and CTSUR master schedule, agency meeting, EU end of trial notifications, pediatric investigation plans, into one computer reporting system.

Ensure that documents and records are appropriately created, captured, accessed, managed and stored in a manner that reflects business, corporate and regulatory compliance requirements.

Develop protocol, generate the required documented evidence to support the (IOPQ) effort of the GMC TrackWise system. Merged multiple instances of TrackWise between Pfizer and Wyeth respectively TrackWise (4.8, 5.9 and 6.0)

Johnson & Johnson Springhouse-Pennsylvania December 2009 to March 2010

Laboratory Program Manager (4 sites)

Laboratories included: Raritan NJ, Radnor PA, Springhouse PA, Malvern PA. Managing multiple, complex projects and managing the programs budget, validation strategies and project delivery teams.

Johnson & Johnson Bridgewater PA July 2009 to December 2009

Global Clinical Operations Clinical Trials Change Management for Documentum

Managed the Change Control and CAPA process and validation process for Clinical Trial changes, for help desk (T1, T2 and T3), R&D Applications Group and ITS (Information technology Services) to resolve past and future issues,( Belgium, India, USA)

PFIZER -Bridgewater PA November 2008 to June 2009

(GRC) Methodology Lead, Global Quality Coach for Oracle implementation

Integrated (24) major computerized systems (TrackWise, etc,)

Wrote the Verification Strategy for the project.

Incorporated governance surrounding Oracle’s (R12) application Oracle E-Business Suite and Oracle AIA and Fusion Middleware

Teleflex Medical- North Carolina May 2008 to October 2008

Quality Medical Device Project Validation Manager (5 sites)

Managed five sites utilizing over a half million dollars a month.

Managed the process and product validation of metal and polymer ligation systems, surgical appliers, external skin-stapling devices, polypropylene suture Systems, Needles, Valves, etc.

Managed production activities and developed design files as well as validation requirements.

Illumina - California February 2008 to May 2008

Sr. Software Quality Project Manager Validation

Conducted various GXP, Risk, and technology assessments. Managed the full lifecycle validation of J.D. Edwards EnterpriseOne and Agile PLM

GE Healthcare- Michigan April 2007 to February 2008

Sr. Project Validation Manager IT-QA

Coordinated development of software validation activities for GE Healthcare’s medical devices in Europe and the US

Directed site leaders towards developing; authoring and reviewing and ensuring that all validation activities adhere to global standard processes

Advanced Automation Reading PA November 2006 to April 2007

QA Procedural Process Control Validation Engineer

Wrote for, Advanced Automation’s management plans Software Quality Assurance Plan (SQAP), Global Software Configuration Management Plan (SCMP), and their Package Configuration Specification (PCS) to procure a contract with GlaxoSmithKline to support manufacturing operations.

Centocor Indiana August 2006 to October 2006

Project Management for QA Clinical Validations

Wrote the development of Validation and Quality Project Plan, Functional Specification, Design Specification, Test Protocols Qualifications, verification of (IQ, OQ, PQ) and more.

Boston Scientific -NY April 2006 to August 2006

Medical Device Process Quality Validation Engineer

Developed, designed and executed protocol for IQ, OQ, Process Q, PPQ (Process and Product), PV, MVP, MVR, design experiments, etc. Develop AQL, Sampling plans, LTPD, Normality, statistically define the process. Process diagrams

PFIZER December 2004 to April 2006

Quality Project Manager

Validated The Foxboro (DCS) control system and developed documentation for the Project Initiation Phase, Requirements Phase, Design Phase, Implementation Phase, Installation and Test Phase, Operation and Support Phase for over forty systems

Covance March 2004 to December 2004

Global Remediation Technical Lead Computerized Systems

Remediated laboratory automation equipment that was used to analyze approximately 10,000 samples a day for 120 instruments in 1/3 of the time of other divisions and help prepare the Indianapolis location for an FDA audit

Alcon Pharmaceuticals June 2003 to March 2004

QA Validation Consultant

Became a source of project management, computer validation, software testing, and systems documentation services experience to pharmaceutical companies.

Cardinal Health September 2002 to June 2003

Sr. Quality Assurance/Scientist

Oversaw quality operations for research, manufacturing, clinical packaging, environmental testing, shipping, labeling, Reviewed Batch records, finished products, in-process results, API’s training records, Audited manufacturing and laboratories, trained employees and conduced investigations.

Omnicare Pharmaceuticals January 2001 to September 2002

Full-Time: Sr. QA Compliance Specialist

Provided clinical trials management (Phases I-IV), data analysis and data submission in all major therapeutic categories for the pharmaceutical manufacturers and biotechnology companies. Reviewed/approved all assigned R&D reports, investigations, change controls, calibration records, SOPs, method development, method validation, and stability

Astrazeneca Feb 1995 to Jan 2001

Senior Research Compliance Specialist/ Auditor:

Supported manufacturing, packaging, in releasing products and services. Conducted periodic audits of all facility laboratories, reviewed IND’s, NDA’s, CMC, FDA responses, Stability, Instrument Calibration, Laboratory Investigations, etc.,

Whitehall-Robins July 1992 to Feb 1995

QC Chemist/Compliance Auditor:

Investigated consumer complaints surrounding Advil, Chapstick, Preparation-H, Centrum, Robitussin, Caltrate, Pregnancy Sticks, Today’s Sponge and more. Audited notebooks for over fifty-two chemists

Lanett Pharmaceuticals: May 1990 to July 1992

Pharmaceutical Development Chemist:

Maintained the integrity of instrumentation in the laboratory. Conducted method development, purity, cleaning validation, process validation, assays, content and dosage uniformity etc.

Rohm & Hass: June 1988 to May 1990

Pharmaceutical Chemist

Responsible for wet chemical analysis on Anionic and Cationic exchange resins, acid base reactions, discolorations, UV analysis, Separation.

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