Management Quality
Resume:
Goal
To be hired for the position of Project Manager, where I can use my talent and skills to assist the Leadership Team in building a solid mid-management quality team through training, effective project leadership, and individual assessment meetings. This can lead to reducing wasteful spending and increasing savings that could be invested elsewhere in the company.
Accomplishments
Generated company revenue by performing business development and consulting activities to meet growth targets of 25 to 30% per year. Accomplished revenue targets by securing new contracts, expanding existing contract scopes, and managing many large and small scale projects for US and European companies.
Managed direct reports consisting of a cross functional teams; performed quarterly and annual performance reviews; assisted with contract proposal generation, project budgets, and assisted HR with interviewing of new hires and disciplinary actions of existing personnel.
Experienced results driven management professional with thirty (30) years experience in the quality, consulting, project management, validation, auditing, pharmaceutical, and biotech industries.
Managed projects for contract test labs and manufacturers, network infrastructure, building startups, facility expansions, new equipment installations and changeovers, and automation and IT software system implementations.
Managed project with Performance Development training group, Quality, and IT to implement site wide learning management system to harmonize training across plant site using third party hosted system, provided quality oversight to data migration from previous system, and development of ongoing and annual compliance training content in partnership with Subject Matter Experts.
Special Skills
Worked in facility start-ups, manufacturing, internal/external audits, business analysis, change management for shutdowns/turnovers and IT data center relocations, compliance, incident investigations, batch record reviews, training systems, learning management systems, document management, training, continuous improvement projects, consulting, validation, IT, quality assurance, R&D, project management, data center relocations, and utilities.
Able to design custom strategic solutions to complex issues using an unique blend of hands-on technical experience and management skills to develop strategic business and project plans.
Able to develop relationships that foster collaboration and stimulate innovation across project teams.
Proven track record for improving business operations and efficiencies.
Performed remediation activities to assist clients with regulatory observation responses and actions.
Participated as consultant in internal and external audits for continuous improvement projects of quality management processes.
Ensure adherence to QA standards across QA and partner teams.
Ability to thrive in a dynamic and fluid organization where priorities shift to respond to changing business needs.
Practical knowledge and application of cGMP compliance and other related regulations.
Ability to work in a challenging environment with frequent interruptions, changing priorities and deadlines.
Employment History
Validation Lead, Laboratory Information Systems: (contract) Gilead Sciences (2015)
Provided GMP validation lead support to implementation and qualification of laboratory information systems used for data transfer from contract labs to internal Gilead systems.
Accomplishments:
Led validation effort for implementation of data package transfer process from contract laboratories to support deployment and production implementation in twelve weeks.
Quality Manager, Business Systems Administrator: (contract) InterMune (2014 - 2015)
Provided GMP IT business systems administration and support for corporate Quality Enterprise IT systems including change management for Quality Enterprise IT systems such as Sharepoint, LiveLink EDMS, Pilgrim QMS, and ComplianceWire Learning Management System.
Accomplishments:
Managed vendors and IT to address and resolve system issues and appropriately communicated gating items to management, Business Process Owners, and users to implement solutions in a timely manner.
Led the development, change management, and validation of software implementation projects involving existing or new systems to improve the overall accuracy, efficiency, and effectiveness of the business processes.
Business Systems Analyst II: Bayer/Talecris/Grifols (2013 - 2014)
Performed IT administration and support for corporate Trackwise QMS applications, relational databases, and servers. Oversaw project management, functional requirements, functional design, technical design, development, testing, and implementation of applications, network, and infrastructure.
Implemented changes to Laboratory Incident Reporting process by merging laboratory incident and sample incident to harmonize process.
Implemented changes to incident process due to continuous improvement project to simplify workflow and consolidate incident types.
Senior Quality Associate II: Bayer/Talecris/Grifols (2003 - 2013)
Provided project management, quality assurance oversight for compliance, audits, system management, development, validation, change management, incident/CAPA, and implementation of global GMP enterprise quality systems.
Accomplishments:
Managed implementation of Learning Management System to Plasma Centers and then to manufacturing site. Participated in vendor audit of the third party supplier for system. Worked with training group to implement training curriculum process, and administrative process for system operation. Provided quality oversight to data migration from previous training system, and change management of functional changes.
Provided lead quality oversight to third party service provider on change advisory board for network and infrastructure changes for data center, physical and virtual server environments, OS patching, security patches, and corporate network.
Provided quality compliance expertise to internal and external audits, internal continuous improvement projects, plasma center integration to business, and laboratory and clinical system processes.
Provided oversight to data center relocation and hardware refresh projects for Bayer divestiture to Talecris, third party support, and relocation of data center infrastructure to company facilities.
Provided quality assurance oversight to integration of US plasma donor centers into the Talecris organization. Reviewed and approved IT validation documentation and procedures prior to FDA inspection of new centers for approval of licensure.
Provided quality oversight to development and implementation of ACSIS barcoding system for plasma unit verification and interface with SAP that was used to label, track, inventory, and disposition source plasma for manufacturing areas, which gave significant increase in tracking abilities and faster throughput of stored plasma.
Supported IT project for implementing plasma warehouse management system replacement by providing quality oversight to review and approval of system development lifecycle documentation, which increased pool processing, and significantly decreased time to locate discrepant units.
Performed quality assurance oversight to incidents and CAPA process in QMS.
Authored and reviewed Standard Operating Procedures (SOPs) for GXP applications and processes using GAMP 5 methodology.
Provided quality oversight to SAP system changes related to configuration changes, new functionality for implementation of Canada and Germany offices, transition of SAP related to Bayer divestiture of plasma business, and technical upgrades of system.
Provided quality oversight to agile testing of IT software being developed in-house to support testing of donor plasma.
Maintained quality oversight of corporate, site policies, and procedures for compliance to FDA regulations and EU Annexes, and industry standards for enterprise computer systems involved with the manufacture, testing, release, and distribution of biotherapeutic drugs.
Project Manager: KMI/PAREXEL (1995 - 2003)
Provided project management, auditing, validation, quality, and compliance consulting, writing and execution of validation/qualification protocols, writing and executing testing for facilities expansions and startups, equipment, utilities, lab systems, IT systems implementation, and manufacturing control systems.
Accomplishments:
Generated company revenue by performing business development and consulting activities to meet growth targets of 25 to 30% per year. Accomplished revenue targets by securing new contracts, expanding existing contract scopes, and managing many large and small scale projects for US and European companies.
Managed direct reports consisting of a team of nine (9) engineers; performed quarterly and annual performance reviews; assisted with contract proposal generation, and assisted HR with interviewing of new hires and disciplinary actions of existing personnel.
Managed projects for contract test labs and manufacturers, network infrastructure, building startups, facility expansions, new equipment installations and changeovers, and automation and IT software system implementations.
Performed role as quality assurance staff augmentation to companies for review and approval of change management, incident management, procedure development, and computer validation documentation.
Management review of contracts and project budgets, business development, oversight of policies, procedures, validation documentation, and expanding business relations with new and existing clients in the biotech, pharmaceutical, and medical device industries.
Performed remediation activities to assist clients with regulatory observation responses and actions.
Performed GAP Analysis of validation documents for equipment and processes on multiple project sites for new and updates to existing NDA submissions to the FDA.
Developed guidelines to standardize validation protocol development and testing approach for equipment and processes to cut expenses and accelerate project timelines.
Performed function as Computer Validation Integrator for various computer related validation team projects, authored computer validation plans, user requirements specifications, system design specifications, testing plans, executed testing plans, and provided technical guidance with manufacturing and process related control systems, and related electronic records requirements.
Expertise
Programming languages: SQL, PLCs.
Tools: SQL Developer, Toad, MS Access, MS Excel, MS Project, MS Word, MS Powerpoint, Visio, GAMP 5, Risk Management, Agile/Waterfall Testing
Databases: MS Access, Oracle, SQL
Applications: Trackwise 8 QMS, HP Service Manager, HP Quality Center, Pilgrim eQMS, Sharepoint, LiveLink, Learning Management Systems, Document Management Systems, LIS, Empower, SDMS, Chromeleon, TotalChrom, LabVantage, Agilent
Education
East Carolina University
BS Industrial Technology/Computer Science (1988)
East Carolina University
MS Industrial Technology (1993)
Edward Markarian
mailto:acrjih@r.postjobfree.com
1129 Manchester Dr
Cary, NC
29511, US
acrjih@r.postjobfree.com
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