Quality Assurance Manager

Summary

Senior Quality Assurance professional with diverse expertise in the

pharmaceutical industry and computer system validation. Proven ability

working with cross-functional teams providing leadership, vision and

direction in developing compliant, quality and efficient solutions to

validate and implement computer systems supporting business objectives.

Strong communication skills and ability to work with all levels of the

organization. Collaborative leadership style with a sincere interest in

growth and development of team members to achieve success through problem

solving and process improvement.

QUALIFICATIONS

. Extensive knowledge of GxPs (GLPs, GCPs and GMPs), 21CFR Part 11,

GAMP5, System Development Life Cycle (SDLC) Methodology, change

control processes, document control and quality systems

. Developed, implemented and maintained training program for direct

reports to assure compliance with GxP regulatory areas.

. SME for development, implementation and continuing education for

global CSV training initiative

. Hands on auditing experience: Computer System Vendors, Contract

Research Organizations, internal audits of business processes and

computer system validation, CAPA program, and ISO 9001: 2008

. Involved in multiple FDA inspections, ranging from being the person

being interviewed, leading the inspection as the quality assurance

lead, having to directly interact with the FDA in answering questions,

preparing business people on how to answer questions and creating the

responses to 483 inspection observations.

. 12 years direct management experience

. ASQ Certified Quality Auditor

. Proven ability to author Quality Management System CSV standards, SOPs

and validation deliverables

. Proven ability to adequately resource and assure completion of change

control processes and associated document control as per project

timelines.

PROFESSIONAL EXPERIENCE

Pfizer Corporation, Peapack, NJ OCT 2010 to present

Consultant, PGM-BT

. Responsible for authoring verification deliverables for regulated

computer system projects. Deliverables included migration strategies,

process flow diagrams, requirements and use case development, and

summary completion report.

. Coordinated testing performed in US and United Kingdom.

. Responsible for quality review of testing documentation.

Schering Plough RESEARCH INSTITUTE/Merck, Summit, NJ 2006-2010

Manager, SVU Quality

Directed a cross-divisional Computer System Validation Quality Unit to

assure real time quality reviews were performed to assure that the computer

systems used to satisfy regulated business objectives were validated

according to FDA regulations and internal company standards

. Managed seven computer system validation quality professionals to

assure computer validation projects were validated according to GxP

regulations and company computer system validation standards

. Identified GxP training gaps in managed quality group. Developed,

implemented and maintained training program.

. Led the development and implementation of the Schering Plough Research

Institute Computer System Validation Vendor Management Program

. Collaborated with cross-functional teams, continuously improving

global computer system validation standards to improve efficiency and

compliance

. Primary author on several global CSV standards and SME and contributor

on six other global Quality Management System CSV standards

. SME for development of company-wide training program for the

implementation of global CSV standards

. Developed and presented Lessons Learned for global CSV continuing

education program

. Intimately involved with assuring the CSV change control and document

control processes were adequately resourced and completed as per

project schedule.

Novartis Pharmaceuticals, East Hanover, NJ 2003-2006

Global Head Quality Management, Development Information Technology

Directed a global quality management unit responsible for assuring that

department's quality system was adhered to and also to continuously drive

improvement of the quality system.

. Drove continuous improvement of the quality system to meet and sustain

compliance with internal and external regulatory requirements globally

. Contributed to appropriate business decisions in the definition and

assessment of IT requirements.

. Ensured adherence to QM related documentation standards during the

business solution lifecycle.

. Managed two senior Quality Assurance (QA) professionals globally

. SME responsible for working with a global team of CSV professionals to

revise two CSV global standards

Schering-Plough Research Institute, Lafayette and Kenilworth, NJ 1998 -

2003

Manager Worldwide Research Quality Assurance Computer Validation Unit

Initiated the creation of a divisional Computer Validation Unit to assure

that computer system validation was performed consistently across

divisional units and the documentation produced was developed in compliance

with FDA regulations and internal divisional standards.

. Established Computer Validation Unit (hired, trained and managed 5 QA

professionals) responsible for assuring that computer and automated

systems installed across the division (GLP, GCP and GMP customer

groups) were developed, tested, installed and maintained in accordance

with applicable regulations and internal standards.

. Scheduled, conducted, created audit reports and performed CAPA follow-

up activities for CSV vendors

. Developed Computer Validation Unit SOPs

. Developed, implemented and maintained training for staff on Computer

Validation Unit SOPs

. Assisted in the development of a divisional 21 CFR Part 11 Policy and

implementation plan

. Key member on division wide team to develop SDLC methodology for the

validation of computer and automated systems

Supervisor Worldwide Research Quality Assurance (1996-1998)

Responsible for assuring that regulated customer groups adhered to

regulations and internal Standard Operating Procedures by performing

regularly scheduled audits and being available to provide regulatory

guidance on solving business problems.

. Primarily responsible in assisting regulated customer groups (GLP, GCP

and GMP) in establishing and maintaining a SDLC for computer and

automated systems for compliance with applicable regulations.

. Assisted supervise the Worldwide Research Quality Assurance - Good

Laboratory Practice (WRQA - GLP) Unit compliance program, including

scheduling, and evaluation of SPRI Drug Metabolism (DM) as well as

other customer groups supporting SPRI DM GLP programs on a worldwide

basis.

. Developed and conducted training to customer groups on subjects of

computer validation.

. Scheduled, conducted, created audit reports and performed CAPA follow-

up activities for CSV vendors

Senior Quality Assurance Specialist (1981-1996)

Toxicology Technician (1978-1981)

EDUCATION

MS Computer Science, Fairleigh Dickinson University Teaneck, NJ

Bachelor of Science Degree - Animal Science, Pennsylvania State University,

University Park, PA

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