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Quality Management

Location:
Rensselaer, NY, 12144
Posted:
May 25, 2016

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Resume:

Proven leader with **+ years in healthcare, biotechnology and drug development.

Experienced in building and leading strategic, technological and operational changes.

International Regulatory/Quality experience

Demonstrated expertise in delivering results with both strategically and operationally focused teams.

Top performer with a track record of delivering measurable enterprise value to the bottom line through identifying opportunities, analyzing benefits, and executing action plans.

Effective in creating a positive and accountable culture focused on balancing results with associate growth and development..

Skills Summary

Team Building and Leadership

Process Improvement

Operational Planning

Excellent background in method development, training, validations of equipments and analytical methods,LIMS implementatin and IND filling.

Execellent Customer Service

Organizational Development

Experienced in developing and implementing regional and global quality programs for GMP and GLP laboratories

Drug Development

Skilled in FDA, EMEA, Canada, Japan and other International Regulatory agencies inspections and expectations

Reference Lab Operations

Strong Ananlytical Skills

Strong understanding of Statistical analysis and metrics-driven improvment

Professional Experience

REGENERON PHARMACEUTICALS

Director of Supply Chain Synchronization, May 2014-current

Work closely with all groups at Manufacuring Site to ensure business needs are met

Forecast driven planning of resources, equipment and infrastructure

Metrics to measure materials and information flow in order to determine performance gaps

Process improvement to achieve targeted business goals

Develop and deliver forecast and resource planning tools to all departments in IOPS

Design, standardize and implement performance metrics

Implement management review and corrective actions processes

Support departments to identify/improve/modify processes to meet targeted goals

Align IOPS departments operations management goals with supply chain planning parameters

Re-design Supply Chain organization to meet the increasing complexity of multiple products at different stage of drug development

Develop a forecast model for strategic growth planning and implementation

Lead External Manufacturing (fill and finish) and Supply Chain Compliance Team

DIRECTOR OF QUALITY CONTROL, January 2012-May 2014

Oversee work planning and technical guidance to lab personnel

Oversee data analysis and review and release of product

Oversee assay transfer internally from R&D to the QC laboratory or from Process Sciences to the QC laboratory

Act as QC liaison to External Manufacturing regarding transfer of identification assay to fillers and the performance of bioburden and sterility testing at the fillers

Oversee technical and regulatory reports, SOPs, Transmittals, CAPAs and CCs for area. Responsible for investigations for OOS deviation

Oversee quality system for monitoring OOS results, atypical results and invalid tests release intermediate and final product

Provide information to investigators as needed during regulatory audits

Ensure quality and regulatory compliance

Prepare annual employee evaluations and recommendations

Lead Operational Excellence and put processes for smooth operations in all labs across QC (Chem, Biochem and Micro), 80% backlog reduction in 6 months.

QUINTILES,INC.

EXECUTIVE DIRECTOR, GLOBAL QUALITY ASSURANCE& DATA MANAGEMENT SEPT. 2007 – NOV 2011

Developed Metrics for QLAB-performance and quality metrics

Lead several process improvement projects like Complexity metrics (Quality before launching a protocol), Demographics Quality process for QECG using Six Sigma Tools

Developed Culture of Quality Program for QLAB and QECG teams

Initiated and lead ISO 15189 cetification program for QLAB

Lead development of tools like Root Cause Analysis, Impact Analysis process for investigating quality incident and compliant

Lead the development of Quality Assurance strategy map

Lead a global team, participated and lead inspections world-wide.

Participation in selection and implementation of LIMS system-modular approach.

Implemented Effectiveness Check process in CAPA for continuous improvement.

Lead re-engineering Trackwise (QA database) through Quality By Design process

Managed the team of 55 employees worldwide with best in class ‘management effectiveness score’ of 95%.

Developed ICH level globalized programs for instrument and method validations and technology transfers.

Responsible for profitability-increased 60% revenue/headcount. Managed budgets of up to 5 million per annum.

AMGEN, INC

Senior Manager, QC Labs February 2001 to September 2007

Managed several teams like lot release, stability testing, sample management including up to 19 direct reports

Handled several inspections from regulatory agencies world-wide.

Particpated in several Six Sigma/Lean projects that saved $1 million for QC lab through work effeciencies( team of eight people handling 80,000 samples/year to 150,000 samples/year).

Standardization of specifications and reference standard testing.

Standardize global procedures for sample handling, chain of custody and processes for critical materials management and analytical methods.

Developed direct reports to take leadership roles. Was able to get 20 employees promoted and transferred at different sites.

Development and troubleshooting of several analytical methods using technology like EIA, RIA, PCR and Threshold DNA and HPLC. Automation using Tecan, Biomex Fx and Hamilton

Validated equipments as required by the Federal Code of Regulations 21CFR Part 11.

Excessive experience with commercial and clinical non-conformance and CAPA quality systems.

Major role in implementation of new LIMS system globally- one site at a time.

Lot release,in process testing and quality systems for Phase I clinical trial drugs.

Extensive experience in environment monitoring, water testing, raw material testing, bio burden and sterility testing.

Expirence with moving the commercial production and quality testing off shore.

Expirence with stability programs and change control for analytical methods and specifications.

Clear understanding of USP, ICH and GxP guidelines and lot release.

Developed training documents for sample management, analytical methods like EIA, Volume, Spectrophotometer, Bradford and appearance

Participated in teams and developed training like Employee Development, Quality By Design, Mentorship, and Organization Change Management.

Developed and participated in several strategies like Preparing the Organization for Future-staff development, Managing resources effectively-leadership development, Six Sigma project for improving sample turnaround times

Responsible for budgets of 2 million and profitability of the organization.

Recipient of Spot Stock Award.

BIOSOURCE INC,

Research Scientist October 2000 to February 2001

Developed Cytokines ELISA Kit.

oShort time as opportunity at Amgen was pending.

SPECIALTY, INC.

Supervisor, Central Quality Laboratory, March 1987 to October 2000

Developed and standardized global quality program for harmonization of analytical methods.

Introduce quarterly quality control program and developed reference standards for over 500 analytical methods.

Developed Quality Assurance program for Sample Management area in the reference lab with sample load of 11,000 samples per day.

Developed and implemented training program for employees and clients

Responsible for 60 employees over two shifts

Participated in CAP and CLIA inspections

Analytical Testing and Managed clinical trials for laboratory testing

Planned and implemented Lean laboratory through automation to increase effeciencies and decrease turnaround times for sample testing.

Design and construction of new facilities, development of testing kits for auto-immune and infectious diseases using PCR and EIA technology in Singapore, Asia

Trained and transferred methods to India

Developed and validated about 300 methods using EIA, RIA, HPLC, PCR and Western Blot techniques

Centrally managed inventory, prepared kits and method transfers for about 500 different methods for production in laboratory

Implemented LIMS system-big change globally.

Transferred and validated various testing instruments like ACS 180, Hitachi, ELAN analyzer, etc. and liquid handling robots like Hamilton, Packard, Biotek and Tecan.

Trained over 50 employees at different levels. Wrote over 100 analytical methods

Education

COLORADO TECHNICAL UNITVERSITY – Colorado Springs, CO

Doctor of Management (Organization Development and Change) April 2013

VILLANOVA UNIVERSITY-On Line Program

Master Certificate in Six Sigma- Master Black Belt in Six Sigma and Lean September 2009

UNIVERSITY OF PHOENIX – Woodland Hills, CA

Master of Management September 2007

UNIVERSITY OF PHOENIX – Woodland Hills, CA

Bachelor of Science (Business Management) April 2005

UNIVERSITY OF GUJARAT – Gujarat, India

Bachelor of Science (Microbiology/Chemistry) April 1980



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