Veeva Vault Electronic Management System
Loretta Nwaesei-Edward
Pharmaceutical/Biotechnology Quality Assurance Professional
Frederick,MD
Summary
Accomplished QA professional with over 10 years of progressive experience and proven record of significant, successful contribution in quality management systems, process improvement, and project management. Proven leadership skills with the ability to provide guidance and mentorship to both colleagues and other cross-functional areas to achieve business objectives and company goals.
Overview
13
13
years of professional experience
4
4
years of post-secondary education
1
1
Certification
Work History
Clinical Quality Supply Manager
AstraZeneca
11.2021 - Current
- Successful and timely Quality disposition of clinical supplies of Investigation Medicinal Product (IMP); review of batch records, supporting documentation and addressing product quality issues and possible non-conformances as required
- Increase sponsor oversight by assuring compliance of review and approval of vendor batch records, supply release supporting documentation, and supply related deviations
- Lead and establish continuous quality process improvement initiatives thereby promoting and contributing to site's lean culture
- Employs/communicates performance metrics of supply operations to leadership and help identify/implement improvement initiatives
- Assists in facilitating internal and external regulatory compliance inspections
- Exceptional author and reviewer of quality Standard Operating Procedures (SOPs); thorough review of change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval
- Effective management of work schedule to assure timely quality review and supply of clinical and commercial products
- Effectively assess, review, and close internal IMP related non-conformances in Veeva Vault Electronic Quality system
- Successful mentoring and coaching on compliance related matters to cross-functional teams and direct customers to promote a strong compliance culture, delivering efficiencies, fulfilling business needs, and department goals
- Collaborate with stakeholders and provide Subject Matter Expert (SME) support to assess and provide guidance involving risk management, change control, and compliance audit activities
- Effective training/guidance to cross-functional teams and direct customers on problem solving/Operational Excellence and root cause analysis tools such as 5 Whys, Fishbone, Fault Tree Analysis, FMEA, DMAIC to identify root cause and implement effective corrective and preventive actions.
Quality Assurance At-the-Source Specialist III
AstraZeneca
07.2017 - 11.2021
- Supported evaluation and lot disposition of intermediates and finished bulk drug substance through timely review of batch records, laboratory results and other GMP documents
- Successful on-the-floor inspections of production areas to resolve issues early and to ensure compliance with SOP and regulatory requirements
- Identified and assessed impact of minor and major deviations that may occur during manufacture
- Effectively performed preliminary risk assessment of non-conformance events and assigns criticality levels, including as applicable, identification of root causes and establishment of corrective actions
- Efficient support and back-up for other Quality Units in off-hours to maintain business continuity
- Re-issued batch record pages; issued logbook pages, SPRs and MPRs
- Reviewed both On-the-floor and Off-the-floor Batch Production Record, Electronic Batch Record review, autoclave review, facilities Work Order, and PCS alarm review
- Increased compliance oversight in product changeover, zone promotions, placing QA hold tags, logbook extensions
- Successfully managed compliance approvals of Return to Service of areas and equipment
- Efficient master data setup in SAP
- Effectively provided compliance guidance to Manufacturing team
- Successfully reviewed and dispositioned process intermediates in SAP.
Technical Writer/Lead Compliance Investigator (Fill/Finish Location)
Sanofi Pasteur Biologics
04.2017 - 07.2017
- Drove investigations to true root cause using appropriate investigation tools
- Defined and implemented effective preventative actions to prevent recurrence
- Managed multiple investigations to efficiently meet compliance deadlines and product release dates
- Generated effective deviations/CAPAs reports related to manufacturing/facilities as ongoing support for production
- Collaborated with cross-functional teams to develop and track CAPA plans
- Analyzed process data and evaluated trends to identify major improvement opportunities
- Provided communication plan for on-going deviations & CAPA's
- Effectively created and communicated CAPA plan to responsible parties
- Managed timely completion of deviations, CAPAs, and Change Controls as necessary.
Quality Assurance (QA) Specialist II
Lung Biotechnology PBC. (Subsidiary of United Therapeutics Corporation)
04.2013 - 01.2017
- Managed the company Learning Management System (LMS); created and maintained user groups and curricula, assigned training to users for each job function, retired courses, generated reports as needed, modified users' groups and removed training from users' curriculum or training account
- Ensured timely distribution of latest revision level documentation to all appropriate users and ensure that obsolete documentation was removed from distribution
- Developed, implemented, and revised SOPs for Clinical QA
- Reviewed GCP and systems-related SOPs as needed to assess their adherence to applicable regulatory standards and corporate goals
- Organized and facilitated teams consisting of subject matter experts for the development and/or update of SOPs for various functional areas outside Clinical QA
- Maintained personnel training files (CV, Job Description, and training attestations)
- Assisted with generation of Statement of Work (SOWs) contracts for QA consultants and software license agreements for the company
- Built, developed, and maintained good working relationships with internal and external customer groups
- Assisted in managing the internal and external audit programs
- Supervised and assisted contracted auditors in preparations, performing and coordinating external GCP-related audits (site/vendor/process) and ensured implementation of compliance systems in assurance with FDA regulations, ICH guidelines, and relevant procedures
- Planned and conducted internal audits against approved standard procedures and project specific plans
- Reviewed and ensured quality and clarity of audit reports from contracted vendors and worked with appropriate company personnel to ensure appropriate actions were completed to address audit findings/observations of noncompliance
- Tracked audit findings to drive process improvements and compliance with applicable regulations
- Generated and communicated compliance trends and actions to mitigate compliance gaps and assisted in preparing the company for regulatory agency inspections
- Facilitated sponsor and investigator site audits
- Evaluated and ensured suitable responses were provided/implemented for corrective and preventive action plans (CAPA)
- Reviewed and approved CAPA requests and reports from GCP major/critical deviations and ensured all open CAPA query/status were followed-up to closure in a timely manner
- Assisted in providing GCP QA support to Clinical Operations based on analysis and interpretation of updates to GCP regulations to assure best Clinical/QA practices
- Reviewed clinical study specific documentation including; protocol, protocol amendments, informed consents, clinical study reports, investigator brochures, pharmacovigilance and safety management plans, etc
- Tracked and maintained QA audit database, CAPA database and other QA tracking tools.
Project Coordinator
Cato Research Ltd.
01.2012 - 04.2013
- Managed all aspects of project tracking and reporting by communicating with the project team, sponsor, and clinical sites for both clinical and regulatory projects
- Established and maintained project schedules, budgets, and team resources - Tracked budget and work closely with finance department to review and approve invoicing from vendors
- Maintained documentation on an ongoing basis and regularly reviewing project files to ensure that all filings are up to date
- Assisted in clinical site management for Phase 1 and 2 studies
- Managed the collections and tracking of Confidential Disclosure Agreement, Financial Disclosure Forms and Debarment Statements from multiple clinical sites and investigators involved in clinical trials for submission to the FDA
- Performed data entry into Clinical Trial Management System (CTMS) and for clinical investigator contact information, regulatory document tracking and enrollment tracking
- Maintained and updated SharePoint Site to help facilitate an environment for project team to collaborate on documents, tasks, contacts, events, and other pertinent information
- Created and updated advanced project timelines and Gantt charts
- Worked closely with Project Manager to create agendas and capture meeting minutes and action items in project team meeting for timely distribution
- Worked closely with Functional Team Leaders, Project Manager (PM), and Clinical Research Associates (CRAs) to review and transmit essential regulatory documents to Trial Master File
- Worked closely with Clinical Study Report (CSR) author and PM to perform QC check on final CSR prior to transmittal to the regulatory operations specialist for submission to the FDA
- Facilitated the compilation and submission processes of Investigational New Drug (IND) submissions/amendments and New Drug Application (NDA) amendments.
Regulatory Affairs Labeling Strategy Intern
Medimmune LLC.
05.2011 - 12.2011
- Provided precedent searches and comparison matrices of US Prescribing Information, Summary of Product Characteristics, or other labeling documents
- Supported general organizational activities involving regulatory files, regulatory electronic submissions, approval documents, tracking spreadsheets, and other needed support documentation
- Assisted with annotating regulatory labeling documents, e.g., Company Core Data Sheet, US Prescribing Information from regulatory dossier
- Assisted with Review, QC and proofreading of labeling and labeling comparisons intended for submission to FDA
- Assisted in the formulation of regulatory labeling strategies
- Assisted with miscellaneous labeling projects as needed
- Collaborated with key cross-functional team members to meet or exceed all project goals.
Education
MSc - Regulatory Affairs in Bioscience
Johns Hopkins University
Maryland, USA 09.2009 - 05.2011
BSc - Pharmacology
London Metropolitan University
London, UK 09.2004 - 05.2007
Skills
Professional Development
- ASQ Certified Quality Auditor, 06/2015, Present
- Auditing Technique for Clinical Professionals, 02/2014
- Risk Based Auditing: Effective Compliance Strategies, 05/2014
- Auditor Emotional Intelligence, 12/2014
- Good Clinical Practice Auditing: Principles and Practice, 06/2015, 07/2015
Software
PMD Smart Supplies System
PowerBI
TrackWise
SAP
GQCLIMS
Pas-X
DeltaV
Compliance Wire
Master Control Document Management System
Certification
ASQ Certified Quality Auditor; Jun 2015 to date
Timeline
Clinical Quality Supply Manager
AstraZeneca
11.2021 - Current
Quality Assurance At-the-Source Specialist III
AstraZeneca
07.2017 - 11.2021
Technical Writer/Lead Compliance Investigator (Fill/Finish Location)
Sanofi Pasteur Biologics
04.2017 - 07.2017
Quality Assurance (QA) Specialist II
Lung Biotechnology PBC. (Subsidiary of United Therapeutics Corporation)
04.2013 - 01.2017
Project Coordinator
Cato Research Ltd.
01.2012 - 04.2013
Regulatory Affairs Labeling Strategy Intern
Medimmune LLC.
05.2011 - 12.2011
MSc - Regulatory Affairs in Bioscience
Johns Hopkins University
09.2009 - 05.2011
BSc - Pharmacology
London Metropolitan University
09.2004 - 05.2007