SUMMARY:

• Over 25 years of international experience in IT governance, Project and program management, GxP/SOX regulatory compliance, information security, audit, process, quality engineering, equipment and computer system validation, lean Six Sigma process improvements, business process reengineering, organizational change management, and quality assurance.
• Experienced in development and roll out of projects in globally distributed matrixed team environment, effective communication & supervisory skills.
• Experienced in working with C level executives, and cross functional teams, in global implementation of complex programs.
• Experienced in managing project resources, team allocation, and development on project size up to 100 Million.
• Domain expertise in biopharmaceutical, biomedical, healthcare, automotive, supply chain and manufacturing, beverage, brewery, chemicals.

TECHNICAL/PROFESSIONAL S:

• Six Sigma DMAIC/DFSS Green Belt/Black Belt and lean process methodology at GEHC, 2012
• People Soft, SQR, PeopleTools, RUP, CMMi, MS - Projects 98/2000, MS Office Project Server 2003, Primavera, Enterprise PlanView, Source Forge, Dimension configuration management tools
• 21 CFR Part 210 and 211- (GMP), 21 CFR Part 58 (GLP), FDA 510(k), ICH-E6/E8/2A (GCP), ICH-Q7A cGMP Guidelines for API, 21 CFR Part 50, 54, 56, 312 and 314, 21 CFR Part 11, ISPE- GAMP 4 Validation of Process Control Systems, QSR 820, ISO 13485, EN-46001, FMEA/FTA, SPC
• ISO 9001/ ISO 9000-3, ISO 27001/27002 , TQM, IEC 60601, EU's MDD 93/42/EEC, JGMP, CDMR, AIMD, IVDD, GHTF.SG3.N99-8, 2002/95/EC, EU/RoHS, FDA's 7382.845, FCPA
• Minitab, MS-Visio, iGrafx, Remedy, Lotus Notes, Scrum, JIRA, MindMap

PROFESSIONAL EXPERIENCE:

Confidential, MI

Program/Compliance Manager

Responsibilities:

• As a consulting Program manager with Zimmer, a leading orthopedic medical device manufacturer in the mid - west, on machining process control remediation project involving CNC machine validation, helped client to re-charter the project for better strategy alignment, to QMS, 21 CFR Part 820, ISO 9001, ISO 13485, IEC60601, IEC 62304.
• Helped map the business process from Hazard analysis, to DFMEA, to PFMEA, to Feature criticality assessment for CTQs, to feature verification plan to material inspection sheet, all in validated LiveLink environment. Project was halted due to merger with another medical device company pending unification of their business strategies, projects review, and work force restructuring in the new environment.
• As. Quality and validation engineer with a leading manufacturer of class 2, 3 medical device components including inhaler, platelet rich plasma system, patch injectors for high viscous biologics, and other cross functional medicine for various therapeutic areas. Involved in all areas of new product development, including prototype development through trial run to commercialization, creation of validation plan, design control to 21CFR Part 820, ISO13485, Part 11, covering design and development planning, design verification, design validation, design transfer, risk management using ISO14971, IEC 60601, 62304, DFMEA, PFMEA, batch history record for components and assemblies, IQ,OQ,PQ protocols with summary reports, CAPA investigation, root cause analysis, remedial action plan, effectivity monitoring, support for design of experiments ( Confidential ), Gage R&R using Minitab, injection molding, CNC machine validation, clean room validation, monitoring and trending to ISO14644-1.

Confidential, IL

Consulting Program Compliance/Validation Lead

Responsibilities:

• Infrastructure qualification of Citrix 6.5 XenApp farm capacity expansion, ESX host expansion, VM ware gold image validation, Empower 3 servers, and Oracle engineered ZFS back up appliance (ZBA) storage solution.
• Application Validation- Empower Chromatographic Data/LIMS system, US Hemophilia communication portal
• Business development and solution selling support to Confidential for multiple client engagements

Confidential, MI

IT Program/Compliance Manager

Responsibilities:

• Facilitated adoption of PMO stage gate processes for scrum/agile projects and developed program metrics. Tracked the project health through out the PMO project stage gate review process. Trained and supported the project managers on Agile /scrum stage gate project delivery process to ensure PMO deliverables compliance in HP PPM tool. Met with Project managers, and other stakeholders on regular basis to ensure project progress and to remove any program bottle necks.
• Developed PMO project risk escalation process, to proactively manage risks.
• Facilitated review and adoption of the Information security control frame work, and GRC tool to better align it with GXP and SOX, COBIT/COSO/SAS70/SOC1/SOC2/ PCI- DSS/ISO27001/NIST SP 800/ ISO 27032. Reviewed Sarbanes-Oxley (SOX) compliance assessments for multiple systems (e.g. GLPROD, PeopleSoft, JDE, SAP) change requests, in context of internal control framework.
• Review and update of QMS manual, SOPs, work instructions, templates to keep it current and aligned with 21 CFR Part 820, 211, Part 11, 314, 58, ISO 13485, MDD 93/42/EEC, EU Annex 11, ISO 14971. Updated CAPA and complaint handling, change control, design control, product recall, quality sampling, GxP risk assessment, periodic review, production and process control, and agile project delivery process.
• Engaged in organizational change management initiatives in process simplification in areas of validation, SOX and GxP risk assessment, change control, Agile project delivery process, CAPA root cause analysis, ‘Effectivity' check, and trend analysis in Trackwise and Power Suite environment, internal periodic review and GxP audit
• Review and approval of hundreds of change requests, including remediation of latent change requests to reduce regulatory exposure.
• Diagnostic and Clinical Services on a Mobile Service 360 Asset Management project covering Case /Site/ Inventory management, Planned Maintenance and PO receiving functionalities on iOS based iPad/iPad Mini tablet PCs, while still protecting patient's rmation and Health records. Supported in corporation of application security control frame work to ensure compliance with HIPPA, HITECH, Joint Commission and DNV European and international accreditation for Hospital and Healthcare delivery. Reviewed Source Code Assisted Black Box Assessment (SCABBA) audit findings related to information security, data integrity and the remedial corrective action taken.
• Validation and regulatory compliance of Global publication system (GPS) upgrade for regulatory Electronic common Technical Documentation (eCTD) submission, SQL*LIMS upgrade to LabVantage 6, HP-CMDB configuration Management Data base, DMR/DHR, MES, Oracle GLPROD/PLM/JDE/ PeopleSoft ERP, Siebel CRM system, for global supply chain operations.
• Facilitated drafting of user requirement specification for implementation of Service Now ITSM tool to replace the legacy tool, for incident management, problem management and change management.
• Review of multiple validation deliverables including validation plan, infrastructure qualification plan including disaster recovery plan, data migration/Unicode upgrade plan, technical and functional risk analysis, URS/SRS/SDS, security requirement specification, Test strategy/Test plan, Technical Architecture Design, IQ/OQ/PQ Plan and reviewed Test scripts in validated HPQC environment
• Leading medical device implant manufacturer : As Program Manager/Validation specialist, supported quality, regulatory compliance and validation tasks in all phases of product development life cycle from concept to production in Agile PLM, Page Vision, SAP ECC6 and Trackwise environment: Key s:
• Establishment of PMO best practices related to Risk Analysis (ISO 13485/ISO 14971, ISO 9001, FMEA/FTA)
• Supported internal GxP audit of all processes around Design Control involving design and Development planning, Design verification, Design review, Design transfer, Project management, Manufacturing Quality.
• Defined processes for Technical and Functional risk assessment, validation, complaint investigation, recalls, CAPA.
• Supported adverse event reporting requirements originating through the complaint system; reviewed and approved complaints and complaint closure letters. Investigated root cause analysis on multiple CAPAs in Trackwise.
• Maintenance of corporate QMS and compliance policies in accordance with ISO 13485, QSR 820, ISO 9001
• Documented all validation deliverables, including DFMEA/PFMEA, validation Plan, DMR, and DHF. Validation (DQ/IQ/OQ/PQ) per QSR 820, IEC 60601, 21 CFR Part 11, and GAMP-5.
• Leading Cardio Vascular Device Manufacturer: As consulting Compliance & Validation engineering specialist, supported validation, GxP regulatory compliance, and internal audit efforts across multiple shop floor systems for this cardiovascular device and electro mechanical system manufacturer to QSR 820, ISO 13485, IEC60601, ISO 9001:2008, GAMP-5, MDD 93/42/EEC & 21 CFR Part 11, ISO 14644/ FS 209E class 10k cleanroom, eMatrix PDM, SAP, EtQ QMS & Trackwise environment. Planned and executed in validation protocols, under Design Control. Planned and executed internal audits. Also helped plan Design of Experiment ( Confidential ), Statistical analysis with Minitab, Gage R&R, in support of verification & validation. Created Validation Plan, GXP gap analysis, FMEA/ FTA risk analysis, CAPA investigations in Trackwise, DQ, IQ, OQ, PQ and other validation deliverables.

Confidential, MI

Program Manager Program Manager

Responsibilities:

• Chevron, leading Oil and Specialty lubricant company, Texas: As PMO Program Manager on a global roll out of SAP IS-Oil ECC6 Logistics (SD/MM/PP/WM/IM/QM) implementation project across EAME, Asia pacific region and Americas along with legacy JDE OneWorld/GESCOM system decommissioning project. Provided leadership, PMO program governance, organizational change management, information security, quality assurance, for implementation on an Onsite/Offshore model throughout the PMO stage gate review process.
• BP, leading Global Petroleum Products Manufacturing/Energy Company, IL: As PMO Project/Program Manager on a Financial Process Improvement Project for the Remediation Management (RM) group, through the ASAP/CVP stage gate delivery process in ‘PlanView Enterprise' environment, covering SAP IS-Oil, ECC6 MM/PP/QM modules implementation, integrated with project systems & budget and planning module for effective management of all future RM Projects. Was involved in organizational change management, and setting up of PMO processes for risk/issue management, integrated program planning, stakeholder management, issue & risk management, schedule, resource management, budget control, cost benefit analysis, SAP IMG Configuration management, Information security per US and international regulatory requirements, program deliverables including business continuity and disaster recovery plan, validation and monthly financial metrics reporting and variance analysis for the IT&S group.
• GM/ Onstar, Leading Automotive Company, MI - As PMO/Program Manager on a Vehicle Telematics Program, in a multi-vendor environment, covering multiple interdependent IT applications in an iterative agile SDLC, SDP21, and PMBOK process frame work on an Onsite/Offshore model. Responsibilities included benefits management, stakeholder management, risk management, validation, testing, quality and defect management, six sigma CTQ, program governance, process guidance, KPI/Metrics reporting throughout the program life cycle covering toll gate reviews across multiple release cycles and direct responsibility for a team of about 35 IT staff.

Confidential, MI

Program/ Quality Manager

Responsibilities:

• Development of a customized Bioinformatics system (PharmaMatrix) with ability to text mine along multiple dimensions of knowledge management such as disease, target, gene, Biomarker, Tissues, Safety & Toxicology, in multidimensional database, integrated with Xybion & other external application; Resultant benefits over 2 Bio. dollars cost savings and 2 -3 years savings in the time to market new drugs
• Review and assessment of Confidentiality, Integrity and Availability (CIA) security category of multiple IT systems to set up baseline controls and execution of Corporate Information protection plans (IPMG)/ System Security based on ISO 17799/ISO27001/ ISO27002, CoBIT 4.0, and risk management framework based on ISO 14971
• Six Sigma Value stream mapping, Six Sigma CTQs, SIPOC, JAD sessions, QFD, VOC, Change control, System disaster recovery, ITIL Process for configuration management, Change Management, Risk Management, Issue resolution, Test Planning for System integration, UAT and Performance testing in Test Director, Load Runner & Trackwise environment
• Established RUP/Scrum based PMO Agile project delivery methodology, supported requirement prioritization using QFD in ReqPro environment, functional decomposition, Use case reviews, source forge configuration controls, Quality metrics, KPI dashboard reporting
• Review and updates to QMS processes to align with ISO 9001, ISO 27001, ISO 14001:2004
• Computer System Validation of multiple systems to 21 CFR Part 11, 211, 58, GAMP-4.

Confidential, Indianapolis, IN

Program/Quality Manager

Responsibilities:

• Leadership of matrixed project teams of over 25 personnel, customer relationships, schedule management, Risk management & issue resolution, EVM, Cost management, Quality Management within PMBOK process framework and Primavera environment
• Project Scope Management covering project scope definition, BPR, Work Breakdown Structure (WBS), Project Time Management, Project Schedule development and activity sequencing identifying task dependencies, and Quality management of all CSV and C&Q deliverables. Establishment of ITIL process for Configuration Management, Change Management, Risk Management, Issue and Problem resolution
• Establishment of new PMO processes for System classification (Direct & Indirect impact), risk analysis, change control, Process validation related to batch production of clinical trial supplies including creation & execution of DQ/IQ/OQ/PQs protocols for system validation (HVAC, Building Management System (BMS), ISO 14644 / FS 209E clean room system, Data Historian, Maximo, PLC based Conveyor control system, Pick-to-light, Vertical carousel system, Hot/Chilled water system, Compressed, Clean Air system, Refrigeration System, GMP Chill Room), to 21 CFR part 211, GAMP-4 and 21 CFR Part 11
• Support for Configuration, Validation and Integration of Rockwell MES, BMS, LIMS/GLP related processes with SAP R/3 Logistics ERP system (WM/IM/MM/SD/QM modules)
• Management & review of all PMO process and validation deliverables such as project plan, validation master plan, system validation plans, GxP documents, RTM, Process mapping, SIPOC and Six Sigma CTQs, KPI among others. Tracked the project & validation deliverables and deployment through to its closure. f all the project contractors on client's Corporate Standard Operating Procedures (SOPs)
• Audit review & evaluation of Vendor Quality management system processes for Material Handling and BMS Systems

Confidential, MI

Sr. Business System Analyst/ Project Lead

Responsibilities:

• Work involved VOC, Functional gap analysis, SIPOC Business process re-engineering, Value stream mapping, JAD sessions, QFD, Six Sigma CTQs, Project Scope Management tasks through documentation of Project Charter, Functional user requirements, Use case diagrams, Requirement Traceability Matrix (RTM), Test Case Scenario, User interface screen, Dimensional modeling on Star schema architecture, all through the RUP SDLC process. Interacted with multiple external vendors such as BCBSM/NASCO and others for health plan claims, Actuarial & other data sources for the new data warehouse.
• Managed the project risks through the PMO stage gate project delivery process. Performed project quality management function covering DSS/OLAP/BI/ETL technical assessment, and vendor audit. Validated user requirements through the PMO stage gate review process in MS Project environment.

Confidential, MI

Sr. Business Analyst/Project Lead

Responsibilities:

• For an Automotive supply chain industry, as an SAP Functional Analyst, was involved in SAP R/3 SD/MM/PP/QM modules implementation all through the Project life cycle from business blue printing to go live, covering fit-gap analysis, business process mapping, and configuration. Worked with Business process owners to understand business requirements, pricing policies, pricing strategies, discount structures and supported configuration, Data migration & Test planning efforts. Established processes for System, Integration, UAT, Regression and Performance Testing strategy, Defect Tracking & Validation in Mercury Test Director/Load runner environment.
• Business analysis and data migration for Legacy to PeopleSoft AM module conversion for a Health Insurance carrier. Work entailed facilitating JAD sessions, project planning, implementation, validation & testing.
• Configuration & customization of PeopleSoft HRMS, Purchasing, Asset Management for multiple Healthcare industries.
• Business analysis, & Project support for upgrades to MES Shop Floor Management Systems- Total Equipment Maintenance (TEM), and Electronic Document Management System (EDMS)
• As Program Manager for Alfa Laval, was involved in contract negotiation, project management, qualification, commissioning, validation, audit, for their range of pre-engineered ‘CHEMAP' Bio-reactor, Continuous Media Sterilizer, CIP/SIP systems, purified water system systems, Lyophilisers, plate and spiral heat exchanger, to Bio-pharmaceutical, API, biotechnology, brewery, beverage, and food industries in FDA-regulated environment, per 21 CFR Part 211, GAMP 3, GxP standards. Also took part in organizational change management process (identify, engage and implement) in introduction of SCALA ERP software, and ISO 9001 - 3 years
• As a business consultant with Asia business consultant, engaged in application engineering, and process optimization using design of experiments ( Confidential ) in areas of CIP/SIP, and cleaning validation in bio-pharmaceutical, dairy and brewery industries, using SOPURA specialty chemicals. Conducted risk Analysis using Six Sigma DFMEA and Process FMEA, FTA, reviewed validation documents; and support of client Green Belt personnel in Six Sigma DMAIC/DMADV/DFSS process methodology for new process design and operational improvements-3 years
• As sales/marketing manager with Thermax, ISO 9001 certified designer, manufacturer and supplier of pre-engineered cGMP steam sterilizer, autoclaves, water purification systems, and waste management/environmental systems, Biomethanation Plants, APV plate heat exchangers, hydraulic power packs & process equipment (Fluidized bed dryer, Lyophiliser or Freeze dryer, falling film evaporators) with process automation controls (DCS/SCADA/PLC) to chemical, pharmaceutical, biotechnology, brewery, and healthcare sector. Managed the supervision and administration of the process industry group comprising 10 engineers, that covered all activities from contract negotiation, sale, application, project engineering, installation, qualification, commissioning and validation of very many capital equipment projects- 2.5 years
• As project/sales manager with KSB pumps Ltd., managed sale, contract negotiations, project execution and integration across the enterprise for many complex projects all through the project life cycle from initiation through to turnover and startup, with direct supervision of the project department for the Process industries group comprising 7 Engineers. Participated in product engineering tasks to customize the products to meet client's requirements. Also, participated in organizational change management life cycle (identify, engage, and implement) for a new customized ERP system for production in IBM mid frame AS/400, covering SAP-R/2, PP/MM modules with fit gap analysis, BPR for unified global processes, GUI usability needs, cross functional interface requirement definitions, with emphasis on just-in-time (JIT) inventory, lean and flexible manufacturing and shortened production cycles- 9.5 years
• As Sales and application Engineer with Otoklin and Sulzer licensee SLM Maneklal Industries, sale, contract negotiation, and application engineering of sulfuric acid ring chlorine compressor, water ring vacuum pump with air ejector, pneumatic conveyor system, Pall Gelman / Millipore sterile filtration products, and FS209E class 10000 clean room system - 4 years