David Dumers Email and Phone Number
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As a Senior Leader of Quality & Validation, I’ve strived to be a Thought Leader, Talent Developer, & Innovator who directs and steers organization resources and encourages collaborative ways of working & providing compliant/sustainable Global Quality Systems - supporting the development & distribution of licensed pharmaceutical products, assuring consumer safety. My experience in pharma manufacturing facilities & laboratories (R&D & commercial) includes development, implementation, & enforcement of policies/procedures based on compliance with FDA, EU, Health Canada, & ICH regulations, supporting the manufacture of clinical & commercial biotech therapeutics. I leverage my network & build on collective knowledge for meaningful Pharmaceutical Science & Manufacturing field contributions. I seek to develop education to ensure a trained workforce contributes to the economic viability of manufacturing jobs in a sustainable way. As an advocate for industry-wide commitment toward education & employment for the Intellectually Disabled community, I’m a proponent of such in company diversity strategy. I support ISPE Student Forum & NC Bio-manufacturing Training Consortium initiatives. My energetic & solutions-oriented persona assists me professionally & in my hobby as a performing musician.✪Technical Project Management in 4 full scale facilities’ start-up: automated manufacturing/laboratory systems, Clean Utilities, process equipment, clean room design/qualification, and laboratory equipment/instrumentation. ✪Quality Compliance: validation, change control, investigations, CAPA, global quality systems, inspection readiness/regulatory compliance, vendor/supplier audits, quality agreements. ✪Quality Operations/Control: batch/lot release, raw material control. Quality Control: Biochemical Analysis & EM, GMP laboratory control. ✪Specialties: Regulatory Compliance (CMC), Quality by Design, Quality Risk Management, Good Engineering Practice, Phase appropriate Commissioning/Qualification, Process/Cleaning Validation, GMP Lab Compliance.
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Sr. Qa Manager Validation & Compliance ProgramsLiquidia Corporation Oct 2024 - PresentMorrisville, Nc, Us
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Pq Project LeadTechnical Source Oct 2023 - Apr 2024Raleigh, Nc, UsClient project: Driving master planning, coordination, decision-making, and project management of CQV performance qualification in support of operational readiness for large scale CDMO operations -
Independent Gxp ConsultantRose Consulting Aug 2023 - Oct 2023Client projects: providing owner rep Quality/Regulatory program consulting for Facility Start-up CQV and GxP Operations Compliance for Pharmaceutical Product Development and Commercial Manufacturing in Biotech based business models. -
Director Of Consulting Services Rtp/SoutheastAzzur Group Jun 2021 - Aug 2023Hatboro, Pennsylvania, UsValidation Program Development, Implementation, & Lifecycle Management Quality/Regulatory Systems compliance programs development, phase appropriate implementation, and quality product lifecycle management.Regulatory CMC dossier documentation and data development. IND/BLA submissions for blockbuster vaccine product launch.Led inspections readiness programs. -
Director Of Validation ProgramsKbi Biopharma Mar 2019 - Aug 2021Durham, North Carolina, UsProvided site/corporate staff development and leadership support in Engineering, Validation, Quality, and Regulatory compliance. Managed operational excellence and business agility to support clinical and commercial supply chain operations in a CDMO environment. Executed principle regulatory and client audit support to provide strategic leadership in audit defense. • Led the master planning and development for a new facility start-up and existing facility retrofits, Quality/Regulatory Audit Support (client & regulatory authorities), Gap assessment, Policy & SOP development, and electronic documentation systems remediation to support PAI readiness and commercial supply chain GMP standards for the first client product launch. • Reduced documentation cycle and risk and increased project resource capacity by 5-10% after combining Engineering and Validation teams and workstreams to support the rapid expansion of technical and management resources and facility capacity to increase business growth and cadence. -
Sr. Compliance ConsultantRose Consulting Sep 2018 - Apr 2019Providing expert consulting and project management services to pharmaceutical companies in areas of Quality Systems and Validation subject matter. Specializing in start-up operations and Inspectional readiness.
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Site Quality Head/Corporate Director Of ValidationMedicago Jan 2016 - Aug 2018Site Quality Head: implementation and establishment of global quality system framework supporting clinical manufacturing and commercial launch of novel protein expression manufacturing platform for pandemic flu vaccine products.Corporate Director of Validation Programs: CQV Master Planning and field execution for full scale greenfield facility build and 2 pilot scale sites (FECU; Cleaning & Process PPQs, Analytical Equipment Qualification & Method Validation; Shipping Validation; CCIT/Sterility; E&L testing; CSV IT/Automation). QC Director for laboratory start-up operations: Drug Substance/Drug Product Specification Methods; Unit Operation In Process Analytics; Cleaning Validation method matrix suitability determinations; incoming raw materials analysis qualifications
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Site Director Of Quality Assurance Product Development/Site Director Of ValidationMedicago Jan 2011 - Aug 2018Providing strategic, tactical, and leadership direction for Medicago US Site Quality Assurance and Quality Control activities for programs supporting Quality System Development, QC Lab start-up & method transfer, Clinical material manufacture, and Commercial product launch.Site Leader providing direction for Medicago Corporate Validation activities and programs for equipment/facility; cleaning; process; analytical; and IT Validation.✦ I resourcefully lead optimized performance and influence a culture of quality in QA & Validation operations, training, and talent management. I proudly contributed to commissioning and validation costs being at less than 12% of total capital expenditure for the facility.
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Sr. Manager, Qa Regulatory CompliancePfizer Oct 2009 - Jan 2011New York, New York, UsAt my 5th year of my 9 year tenure at Pfizer (formerly Wyeth Vaccines) I promoted to a Site Head role as Manager of Quality & Regulatory Compliance at 2 facilities.✦ One highlight accomplishment I achieved was setting a historic company precedent as Regulatory Compliance SME for CMC Data Integrity Verifications, supporting the most successful biologically complex product filing. -
Manager, Qa CompliancePfizer Nov 2006 - Oct 2009New York, New York, UsAs Quality Assurance Compliance/Regulatory support for BioPharma Analytical Laboratory and Clinical Trial Material manufacturing, I thrived and had extensive experience in the following areas: ⋆ Facilities start-up and CTM campaign strategies⋆ Adminstration of Corporate Conformance Standards ⋆ SOP development/implementation⋆ Investigations⋆ Quality Engineering/Compliance⋆ Commissioning/Validation Compliance [Equipment (including Distributed Control Systems: ABB, Emerson Delta V), Process, Cleaning]⋆ BOH and internal audit responses⋆ Analytical laboratory operations and compliance
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Sr. Qa Compliance SpecialistPfizer Dec 2004 - Nov 2006New York, New York, UsIn my role as a Quality Assurance Compliance/Regulatory Specialist for BioPharma Analytical Laboratory and Clinical Trial Material manufacturing, I accumulated valuable experience in facilities start-up and excelled at initial campaign strategies.My responsibilities included:⋆ Validation compliance oversite⋆ SOP and Conformance Standard review⋆ Analytical Laboratory Compliance oversite
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Qa Specialist IvPfizer Nov 2001 - Dec 2004New York, New York, UsDuring my 3 year tenure in Quality Assurance Compliance/Regulatory support for BioPharma Commercial Material manufacturing, my position duties ecompassed Quality oversite of SOP development/review/approval, validation review, and maintenance systems review.
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Sr. Validation SpecialistSerentec Inc Mar 1999 - Nov 2001At Serentec I provided Validation consulting services to the Pharmaceutical industry. Client project: major facility expansion to implement new chromatography process to increase production yield of immunoglobulin (IgG) harvested from frozen blood fraction paste.My experiences included: validation of 2 large scale manufacturing equipment trains including: in-process laboratory equipment, buffer prep, dissolution and filter press, large scale chromatography, ultra filtration/diafiltration, formulation, bulk filling and storage.Additionally I performed Technical writing to support: SOP development, eCTD submission, and project engineering change control.
David Dumers Skills
David Dumers Education Details
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Temple UniversityDrug Development Program -
Temple UniversityDrug Development
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North Carolina State UniversityZoology (Pre-Medical)
Frequently Asked Questions about David Dumers
What company does David Dumers work for?
David Dumers works for Liquidia Corporation
What is David Dumers's role at the current company?
David Dumers's current role is Providing GxP Compliance Expertise and Leadership.
What is David Dumers's email address?
David Dumers's email address is da****@****zur.com
What is David Dumers's direct phone number?
David Dumers's direct phone number is +191974*****
What schools did David Dumers attend?
David Dumers attended Temple University, Temple University, North Carolina State University.
What are some of David Dumers's interests?
David Dumers has interest in Social Services, Education.
What skills is David Dumers known for?
David Dumers has skills like Validation, Gmp, Fda, Pharmaceutical Industry, Quality Assurance, Capa, Change Control, Cleaning Validation, Sop, Biotechnology, Pmp, Biopharmaceuticals.
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