Quality Assurance Project Manager

Experience

Director, Information Systems and Technology at QPS Holdings, LLC

September 2010 - Present

Led Automation & Information Technology strategy, project portfolio and service operations during a period of significant business growth and geographic expansion.

• Developed and implemented a comprehensive IT strategy addressing business needs including A/V Collaboration, Client Workstation, Clinical Data Management, Worldwide Data Management, Email, HR, Finance and Accounting, Global Networking, Internet Access and Hosting, LIMS (Laboratory Information Management Systems), Mobile Communications, and Microsoft product, Medical Dictionary (MedDRA) and Statistical software (SAS and WinNonLin) licensing.

• Integrated IT staff, assets and processes of newly acquired entities in Asia and Europe.

• Simultaneously improved performance and reduced cost of Internet and telephone services.

• Established a low-cost, self-managed IPSec Virtual Private Network spanning 3 continents and 9 sites.

• Led decision analysis and implementation of a global HR/Finance/ERP system (NetSuite).

• Upgraded and globalized core business applications (OpenClinica and Watson LIMS).

• Identified non-essential business applications (Blackberry Enterprise Server, Oracle Clinical, Exact/Synergy, Quickbooks) for phase out and retirement.

• Maintained outstanding levels of IT infrastructure service and client satisfaction.

Senior Consultant at Paragon Computer Professionals

November 2008 – September 2010

Enabled global organizations to define and manage effective go-to-market strategies leveraging Automation & Information Technology.

• Led the transformation of global pharmaceutical clinical supply chain management through

implementing Aptuit Informatics' Clinicopia Suite.

• Led the implementation of Mystic Management Systems' ensurDCS to facilitate development and management of pharmaceutical packaging specifications and artwork.

• Facilitated Manufacturing Execution System (MES) vendor selection for a startup nano-bio-tech device manufacturer.

• Managed expansion and upgrade of an industry-leading RFID-enabled pharmaceutical controlled substance delivery chain solution.

• Developed and implemented efficient, effective application architectures using Oracle DBMS, SQLServer DBMS, Oracle Application Server, Java, VMWare, App-V and Serial and Wireless communications technologies.

Biotech Product Manager at Camstar Systems

August 2007 -July 2008

Led Biotechnology market entry for Camstar by providing market analysis, product and program strategy, product management and sales and marketing collateral.

• Established thought-leadership by identifying and justifying optimum manufacturing, quality and business intelligence information technology architecture investments for Medical Device manufacturers and Biotech startups.

• Developed Market Analyses, Product Strategy and Planning, Program Strategy, Sales Readiness and Channel Support for the Biotechnology Industry for award-winning Manufacturing Execution System vendor CAMSTAR Systems, Inc.

Associate Director, Research Information Services at Merck & Co., Inc.

December 2002 -February 2007

Transformed computer validation and application support for Pre-Clinical Research & Development into enduring centers of excellence.

• Optimized delivery of GXP validation and testing services by establishing common Systems Development Life-Cycle (SDLC) best practices which optimally sourced $2.3 million of resources to support Research Information Services' $100 million project portfolio.

• Led master data definition, SOP development, training, quality assurance and validation for a fully integrated global ERP / MES solution.

• Achieved outstanding levels of customer satisfaction in managing Global Clinical Supplies

IT operations.

Project Manager, Information Services at Merck & Co., Inc.

October 1990 -December 2002

Led IT projects for Merck Pharmaceutical Manufacturing Division and US Human Health.

• Transformed a team of software testing engineers into a center of excellence, providing Internet application test automation, and performance tuning services to global ITG projects.

• Led performance tuning and quality assurance teams for Internet marketing portals

MerckMedicus.com and MerckSource.com.

• Led Merck Research Laboratories' Desk-side support teams in Rahway, NJ and West Point, PA, providing unparalleled levels of support to over 2,500 employees.

• Launched a business IT applications Help Desk focusing on Basic and Pre-Clinical Research.

• Led the business analysis, requirements, design, development and deployment of Quality and Regulatory Affairs information systems for Merck manufacturing plants, worldwide.

• Developed strategic and tactical plans for Laboratory Information Management Systems (LIMS) used by Merck Pharmaceutical and Chemical Manufacturing Divisions worldwide.

• Led laboratory automation projects in USA, Netherlands and France.

Manufacturing & Quality Management at Merck Sharpe & Dohme

October 1980 -October 1990

Served in positions of progressively increasing responsibility within MSD Manufacturing.

• Defined functional requirements, coordinated vendor selection, design, development, and

implementation of a Laboratory Information Management System (LIMS).

• Managed resources responsible for pharmaceutical product and medical device

release-to-market.

• Coordinated product stability-related activities, including stability study protocol design, execution, data analysis, and internal and external (FDA) reporting.

• Re-engineered laboratory operations resulting in more rapid procurement of samples for laboratory testing, more accurate and comprehensive sample tracking, and an improved availability of laboratory test data for trending analysis.

• Supervised QC testing of sterile and non-sterile pharmaceutical products.

• Supervised production of Influenza and Pneumococcal Pneumonia vaccines.

• Audited on-site and outsourced pharmaceutical manufacturing, packaging and filling operations.

Education

Lehigh University - College of Business and Economics

MBA, Information Systems Management / Supply Chain Management

Temple University – Graduate School of Pharmaceutical Sciences

MS, Pharmaceutical Quality Assurance / Regulatory Affairs

New York University – Washington Square University College

BA, Anthropology, Biochemistry, Biology, Philosophy

Contact this candidate