Brett Vengroff Email and Phone Number
Brett Vengroff work email
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Brett Vengroff personal email
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Quality professional with over 28 years of experience in the biopharmaceutical industry, supporting GCP, GLP, and cGMP compliance for leading biotechnology, pharmaceutical, medical device, and non-profit organizations. I provide quality assurance, audit and compliance training services to ensure regulatory standards are met with best practices for developing innovative and life-saving therapeutics.My specialties include establishing and maintaining global quality management systems, conducting vendor audits, clinical investigator audits, CMO audits, and CRO audits, designing and improving business process workflows, training programs, and performance management systems. I am passionate about delivering quality solutions that enable companies to achieve their goals and missions. I also leverage my business education from MIT Sloan School of Management to help organizations optimize their operations and strategies.
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Senior Director, QualityPulmovant Nov 2024 - PresentWaltham, Ma, Us
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Principal ConsultantCompliancelogix Jan 2009 - PresentSt Petersburg, Florida, UsComplianceLogix is a Contract Quality Organization (CQO) that provides effective regulatory compliance training and quality assurance consulting services. Our industry experienced consultants provide complete Quality Assurance support including GCP, GLP and GMP training, vendor audits, clinical investigator audits, batch record review, SOP writing, computer system validation, and quality systems implementation.Our clients include industry leading biotechnology, pharmaceutical, medical device and international non-profit organizations developing innovative and life-saving therapeutics. -
General ManagerCambridge Realty Trust Sep 2005 - PresentManages a portfolio of multi-family real estate in emerging markets. -
Advisory Board MemberTop Ten Talent Sep 2021 - Aug 2024Top Ten Talent is a specialized recruitment firm that helps small to mid-sized gene and cell therapy pharmaceutical and biotech companies get their drugs to market. -
Associate Director, Clinical Quality AssuranceCombinatorx Jan 2008 - Dec 2008UsEstablished and maintained quality assurance systems for all clinical programs. Supervised permanent and contract auditors. Performed internal and external quality assurance audits of GCP documentation, investigator sites and clinical vendors. Collaborated with internal and external customers to resolve compliance issues and remove obstacles to effective process. Designed an audit tracking database to trend information and improve audit workflow. -
Sr. ConsultantCambridge Consulting Group 2007 - 2008Provided quality assurance audit and compliance training consulting services relating to regulatory compliance, business process improvement, organizational alignment, training, performance management, quality systems design and execution.
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Manager, QualityVertex Pharmaceuticals, Inc. 2006 - 2007Boston, Ma, UsResponsible for managing operations of the core quality function in support of all regulated areas, including Quality Assurance Documentation, Change Control, Training, and Quality Management. Supervised Core Quality personnel. Defined roles and responsibilities for Core Quality personnel to facilitate cross-training of staff. Implemented change management process for technical transfer of CMC documents. Established procedures for management of vendor documents and traceability for external document distribution. -
Manager, Quality AssuranceArqule, Inc. 2004 - 2006Responsible for leading all quality assurance activities. Established and maintained quality systems to support GCP, GLP and GMP regulated activities. Supervised all permanent and contract Quality Assurance personnel. Established policies and quality systems for Standard Operating Procedures, compliance training, quality assurance audits, deviations and CAPA. Managed GCP, GLP, GMP, and internal compliance audit function. Conducted review of batch records, protocols, specifications, stability, and product release.
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Sr. Compliance Associate, Corporate Drug ComplianceBiogen Idec, Inc. 2003 - 2004Cambridge, Ma, UsParticipated in internal and external quality assurance audit programs. Collaborated with business area experts to ensure compliance with GxP regulations. Conducted audits of sales call records and physician payment information. Participated in quality assurance audits of suppliers and clinical investigator sites. Designed and developed quality assurance audit tracking database to capture compliance metrics across sites. -
Qa Systems Manager, Quality ManagementBiogen Idec, Inc. 2000 - 2003Cambridge, Ma, UsResponsible for the development and oversight of quality assurance documentation, compliance training and continuous mprovement to support drug development activities in North America and ROW. Supervised Quality Assurance Systems group. Aligned compliance training and quality assurance documentation systems worldwide for Medical Research, Pharmaceutical Science & Technology, Preclinical & Clinical Development, and Regulatory Affairs to improve compliance and standards across the organization. Defined integrated process maps for drug development with defined milestones, deliverables and performance metrics. Identified and implemented computer-based training documentation and delivery systems.
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Operations Analyst, Clinical Quality AssuranceBiogen Idec, Inc. 1997 - 2000Cambridge, Ma, UsAnalyzed critical business processes to assess quality, effectiveness and appropriate use of technology. Coordinated the design, development and implementation of process and system improvements. Managed quality systems for Medical Research and Regulatory Affairs Standard Operating Procedures. Supervised Quality Assurance Documentation group. Designed and implemented electronic system for enterprise-wide access to Standard Operating Procedures and other quality assurance controlled documents. Implemented process improvements to adverse event reporting process to reduce file waiting time and repetition of editing steps - resulting in 30% overall step reduction, reduced cycle times and improved quality. Trained 300+ employees worldwide on quality assurance procedures for Standard Operating Procedures, Training and Regulatory Agency Inspections.
Brett Vengroff Skills
Brett Vengroff Education Details
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Mit Sloan School Of ManagementBusiness -
University Of ConnecticutMa
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Stony Brook UniversityBa
Frequently Asked Questions about Brett Vengroff
What company does Brett Vengroff work for?
Brett Vengroff works for Pulmovant
What is Brett Vengroff's role at the current company?
Brett Vengroff's current role is GCP, GLP, cGMP Compliance Training, Audit and Quality Assurance Professional.
What is Brett Vengroff's email address?
Brett Vengroff's email address is yo****@****ail.com
What is Brett Vengroff's direct phone number?
Brett Vengroff's direct phone number is +194158*****
What schools did Brett Vengroff attend?
Brett Vengroff attended Mit Sloan School Of Management, University Of Connecticut, Stony Brook University.
What are some of Brett Vengroff's interests?
Brett Vengroff has interest in Compliance Training, Online Training, Gcp Training, Process Improvement, Process Mapping, Quality Assurance Audit.
What skills is Brett Vengroff known for?
Brett Vengroff has skills like Quality Assurance, Gmp, Capa, Sop, Quality System, Drug Development, Gcp, Clinical Trials, Quality Auditing, Technology Transfer, Process Improvement, Business Process Improvement.
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