Jeff Heller Email and Phone Number
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Experienced Quality Assurance professional with proven ability to develop and implement quality and compliant systems supporting business objectives. Extensive knowledge of GxPs (GLPs, GCPs and GMPs), 21CFR Part 11, GAMP5 and System Development Life Cycle (SDLC) Methodology(IQ,OQ,PQ) 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 Experience working with cross-functional teams providing leadership, vision and direction in developing compliant, quality and efficient solutions. 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. Hands on experience developing, implementing and auditing: Computer System Vendors, Contract Research Organizations, internal audits of business processes and computer system validation, CAPA program, and ISO 9001: 2008Specialties: 12 years direct management experience ASQ Certified Quality AuditorPrimary author on several global QMS CSV standards and SME and contributor on six other global QMS CSV standards Strong communication skills, 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.
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Corporate It Validation ManagerValeant Pharmaceuticals Jul 2011 - PresentBridgewater, Nj, UsResponsible for overseeing the validation of corporate systems (GxP and SOX) at Valeant. Responsible for maintaining change control records, IT Training program, creating/revising IT SOPs and policies. Responisble for providing computer validation oversight and guidance to companies manufacturing sites.
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Consultant, Pgm Bt CompliancePfizer Corporation Oct 2010 - Aug 2011• 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.
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Quality ManagerSchering Plough Research Institute/Merck Research Laboratories Aug 2006 - Aug 2010Directed 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 standardsManaged seven computer system validation quality professionals to assure computer validation projects were validated according to GxP regulations and company computer system validation standardsIdentified GxP training gaps in managed quality group. Developed, implemented and maintained training programLed the development and implementation of the Schering Plough Research Institute Computer System Validation Vendor Management ProgramCollaborated with cross-functional teams, continuously improving computer system validation standards to improve efficiency and compliancePrimary author on several global CSV standards and SME and contributor on six other global Quality Management System CSV standardsSME for development of company-wide training program for the implementation of global CSV standardsDeveloped and presented Lessons Learned for global CSV continuing education programIntimately involved with assuring the CSV change control and document control processes were adequately resourced and completed as per project schedule.
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Director/Gllobal Head Quality ManagementNovartis Pharmaceuticals Aug 2003 - Aug 2006Basel, Baselstadt, ChDirected a global quality management unit responsible for assuring that departments 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 globallyContributed 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 globallySME responsible for working with a global team of CSV professionals to revise two CSV global standards -
Manager Worldwide Research Quality Assurance Computer Validation UnitSchering-Plough Research Institute Jan 1998 - Jan 2003Kenilworth, New Jersey, UsInitiated 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 vendorsDeveloped Computer Validation Unit SOPs Developed, implemented and maintained training for staff on Computer Validation Unit SOPsAssisted in the development of a divisional 21 CFR Part 11 Policy and implementation planKey member on division wide team to develop SDLC methodology for the validation of computer and automated systems -
Supervisor Worldwide Research Quality AssuranceSchering-Plough Research Institute Jan 1996 - Jan 1998Kenilworth, New Jersey, UsResponsible 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
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Senior Quality Assurance SpecialistSchering-Plough Research Institute Jan 1981 - Jan 1996Kenilworth, New Jersey, Us
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Toxicology TechnicianSchering-Plough Research Institute Jan 1978 - Jan 1981Kenilworth, New Jersey, Us
Jeff Heller Skills
Jeff Heller Education Details
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Fairleigh Dickinson UniversityComputer Science -
Pennsylvania State University, UniversityAnimal Science
Frequently Asked Questions about Jeff Heller
What company does Jeff Heller work for?
Jeff Heller works for Valeant Pharmaceuticals
What is Jeff Heller's role at the current company?
Jeff Heller's current role is Corporate IT Validation Manager at Valeant Pharmaceuticals.
What is Jeff Heller's email address?
Jeff Heller's email address is je****@****tis.com
What is Jeff Heller's direct phone number?
Jeff Heller's direct phone number is +190892*****
What schools did Jeff Heller attend?
Jeff Heller attended Fairleigh Dickinson University, Pennsylvania State University, University.
What skills is Jeff Heller known for?
Jeff Heller has skills like 21 Cfr Part 11, Computer System Validation, Gxp, Change Control, Fda, Validation, Quality Assurance, Pharmaceutical Industry, Capa, Gmp, Glp, Cross Functional Team Leadership.
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