Summary
Overview
Work History
Education
Skills
Timeline
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Humphrey Awinyo

North Plainfield,NJ

Summary

Experienced biopharmaceutical and pharmaceutical industry professional with a demonstrated history of success working in the biopharmaceutical, pharmaceutical and personal care industries. Skilled in Management Process Mapping Re-design, Life Sciences, Cell Therapy, Validation and Data Integrity/Compliance Auditing. Strong Information Systems professional with a Master of Business Administration (MBA) degree in Management Information Systems. Insightful Manager with experience directing and improving operations through effective employee motivational strategies and strong policy enforcement. Proficient in best practices, market trends and regulatory requirements of industry operations. Talented leader with analytical approach to business planning and day-to-day problem-solving.

Overview

17
17
years of professional experience

Work History

Manager, Equipment Commissioning & Qualification – Computerized Systems Delivery

Bristol Myers Squibb
01.2020 - Current
  • Responsible for management activities as hiring, objectives definition, communication, performance reviews, professional development, and improvements plans
  • Lead efforts in the implementation and maintenance of a risk-based qualification model with resultant elimination of unnecessary or duplicative testing
  • Lead validation and compliance consulting and project work on various technology development and implementation projects viz., global harmonization and implementation of ValGenesis and NuGenesis
  • Lead initiatives to improve and simplify processes leading to the evaluation, development, and implementation of CSA
  • Responsible for providing oversight of all site system related issues and ensuring that systems are maintained in a validated state throughout their lifecycle
  • Responsible for ensuring that system data integrity is maintained throughout the system data lifecycle
  • Responsible for leading and monitoring IT quality processes for internal audits and assessments and maintaining a state of inspection readiness
  • Lead and contribute documenting RACIs for the IT CSV, IT Change Management, and key IT processes
  • Facilitate the Demand Management process for all requirements in projects and changes for IT CSV to determine the needs of CSV resources and capabilities
  • Support IT in documentation of incidents/ issues and QA Deviations in compliance with GxP and following SOPs related to deviations and CAPAs
  • Provide oversight of system related issues, employ risk-based methodology, lead teams on assessments and ensure that all GxP computerized systems are maintained in a validated state throughout their lifecycle
  • Developed a Compliance Plan and SOP for Periodic Reviews of all site GMP computerized systems
  • Lead compliance programs for Change Management, Deviations, CAPAs, Data Integrity and Periodic Reviews
  • Maintain close relationships with QA, IT, Quality Systems and Regulatory organizations to maintain alignment with IT Compliance Assessments
  • Responsible for maintaining site validation master plan and a listing of all site GMP and non-GMP computerized systems
  • Lead validation processes and procedures in developing, managing, and maintaining full SDLC validation deliverables for regulated computer systems, including validation and test plans, URS, UAT, IQ/OQ, VSRs and RTMs
  • Work with business and business process owners to assist in the development of user and functional requirements specifications
  • By implementing business process redesign, have reduced the time from the installation of systems to release by 80% as Site Computer Systems Validation SME
  • Implementing and driving digital transformation by eliminating paper-based testing and implementing automated testing
  • Cycle time will be reduced by 75%
  • Experienced with HP ALM
  • Leverage analytics and business intelligence established methods and procedures for ensuring computerized systems are released in a timely manner and workload is evenly distributed
  • Responsible for key thought leader advocacy in the adoption of new technologies to facilitate process improvements by anticipating business and industry challenges and make recommendations on best practices to help in the improvement of products, processes, and systems
  • Solve problems during validation process and address/advise on issues such as deficiencies, deviations, and change controls
  • Ensure initiation/preparation and closeout of all CSV related deviations.

Senior Manager, Global IT GxP Infrastructure / CSV Quality and Compliance

Wipro Ltd @ Takeda
01.2014 - 01.2019
  • Provided quality and compliance oversight and direction for IT infrastructure qualification (because of change in delivery model from on-premises to external hosting) at Takeda sites globally and served as a liaison between site and global quality and compliance heads
  • Spearheaded the transition from paper-based document approvals to electronic document approvals using an Electronic Document Management System
  • Managed along with the global heads of quality and compliance, site-based self-compliance audits of documentation repositories and in-process audits of adherence to SOPs
  • Interacted with regulatory agencies (e.g., FDA, MHRA, EMA) and internal auditors presenting/explaining CSV documentation and processes, sharing details about IT GxP processes and establishing actions plans for any possible observation or recommendation
  • Worked with overall project managers to include validation activities in implementation timelines
  • Led and conducted system compliance risk assessments to determine decisions for validations and scope
  • Strengthened knowledge and understanding of US and EMA regulations and laws governing the pharmaceutical industry, viz; cGxPs (cGMP, cGLP, cGCP, cGDP, cGVP), WHO, EU GMP, and HIPAA), GAMP 5, electronic records and electronic signatures as well as issues impacting data privacy and data integrity through personnel training, SOPs, and guidelines for Wipro employees
  • Strengthened knowledge of regulations and laws governing the pharmaceutical industry in other geographies, i.e., EudraLex, MHRA, and Japanese PMDA for Wipro employees by leading classroom training
  • Strengthened IT controls for providing assurance of data integrity throughout the lifecycle of data by creating SOPs, Work Instructions and Policies in alignment with global SOPs
  • Worked with cross-functional teams across multiple geographies.

Manager, Computer Systems Validation

G&M Health, LLC
01.2013 - 01.2014
  • Managed the revamp of the validation consulting business by launching a new revenue stream in the temperature and humidity mapping space, supporting pharmaceutical cold chain distribution
  • Mentored and motivated a team of 6 consultants to have a broad spectrum of capabilities to support the growing business
  • Led validation processes and procedures in developing, managing, and maintaining full SDLC validation deliverables for regulated computer systems, including validation and test plans, URS, UAT, IQ/OQ, VSRs and RTMs
  • Led and conducted system compliance risk assessments to determine the decisions for validation and scope
  • Collaborated with project stakeholders and the IT team to define needs and achievable solutions and/or justifications to system requirements
  • Collaborated worked with clients in the management of risk-based strategies in validation of regulated IT systems
  • This required a thorough understanding of System Development Life Cycle (SDLC), GAMP 4 & 5, 21 CFR Part, 211, 820, 11, and Annex 11
  • Managed development of validation strategy and validation deliverables while ensuring adherence to 21 CFR Part 11 and EU GMP Annex 11, ICH Q9 and HIPAA during development of validation deliverables.

Global Compliance Lead (CSV) Consultant

Rose International @ Janssen Pharmaceuticals
01.2011 - 01.2013
  • Spearheaded the global deployment of chromatography data software (Empower 3) following a risk-based approach utilizing GAMP SDLC methodology
  • Ensured the test approach employed was risk-based
  • Developed test cases using HP Quality Center and utilized Documentum as a repository for validation deliverables and TrackWise for initiation of change controls
  • Ensured proper development and management of GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, Traceability Matrix, Validation Reports, SOP's, Change Control Documentation, and Risk Assessment reports
  • Collaborated with project stakeholders and the IT team to define needs and achievable solutions and/or justifications to system requirements
  • Worked with cross-functional teams across multiple geographies.

Project Manager/Quality Assurance Consultant

Agile1 @ Merck
01.2010 - 01.2011
  • Reviewed validation protocols and reports for CIP, SIP systems, CTUs, and autoclaves
  • Conducted quality system assessment for CAPA conformance.

Computer Systems Validation Consultant (Independent Consultant)

Sentinel Consulting Group @ GSK
01.2009 - 01.2010
  • Served as Validation Lead for validation of computerized laboratory systems; provided regulatory expertise and drove adherence to 21 CFR Part 11 and Compendia requirements for EP, USP, and JP.

CSV Consultant (Independent Consultant)

RCM Technologies, Inc. @ Wyeth
01.2008 - 01.2009

Mid Atlantic Multi-Vendor Support Specialist

PerkinElmer
01.2007 - 01.2008

Education

MBA - Management of Technology

New Jersey Institute of Technology

BS - Biology

New Jersey City University

Skills

  • 10 years’ experience in management of technical employees
  • Experience in SDLC, CSV and infrastructure qualification in GxP environments in the biotechnology and pharmaceutical industries
  • Solid understanding of industry regulations including FDA, PDMA, MHRA, EMA, PIC/S and WHO
  • Expertise in GLP, GMP, QSR as applicable to electronic records and signatures as well as data integrity and data governance
  • Periodic Reviews
  • Computer Software Assurance
  • Expertise in operating systems, database structure, system security, configuration, and design of test scripts
  • Knowledge of principles, methods, and procedures of clinical research and pharmacovigilance
  • ITIL
  • Quality Risk Management
  • Access Monitoring Management
  • Project Management
  • Root Cause Analysis and CAPAs
  • Deviation Investigations
  • Conducting and Managing Audits
  • Digital Transformation
  • Data Analysis (Power BI, Empower)
  • Quality Systems Software (TrackWise, Veeva, Qumas, Documentum)
  • Test Software (ValGenesis and HP ALM)
  • Collaboration Platforms (Smartsheet, SharePoint and DocuSign)
  • Microsoft Office (Word, Excel, PowerPoint, Project, and Visio)
  • ServiceNow and BMRAM
  • Key Performance Indicators
  • Team Leadership
  • Verbal and Written Communication
  • Policy Implementation

Timeline

Manager, Equipment Commissioning & Qualification – Computerized Systems Delivery

Bristol Myers Squibb
01.2020 - Current

Senior Manager, Global IT GxP Infrastructure / CSV Quality and Compliance

Wipro Ltd @ Takeda
01.2014 - 01.2019

Manager, Computer Systems Validation

G&M Health, LLC
01.2013 - 01.2014

Global Compliance Lead (CSV) Consultant

Rose International @ Janssen Pharmaceuticals
01.2011 - 01.2013

Project Manager/Quality Assurance Consultant

Agile1 @ Merck
01.2010 - 01.2011

Computer Systems Validation Consultant (Independent Consultant)

Sentinel Consulting Group @ GSK
01.2009 - 01.2010

CSV Consultant (Independent Consultant)

RCM Technologies, Inc. @ Wyeth
01.2008 - 01.2009

Mid Atlantic Multi-Vendor Support Specialist

PerkinElmer
01.2007 - 01.2008

MBA - Management of Technology

New Jersey Institute of Technology

BS - Biology

New Jersey City University

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