David Gallick Email and Phone Number
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The modern manufacturing operation is more complex than ever before, with constantly changing regulatory requirements, tighter delivery deadlines, and clients who demand consistently superior quality. I am a senior executive with a broad background who can meet each of those objectives while building the foundation for continued growth, research, and innovation.With equally valuable expertise in operations management, manufacturing, quality assurance, and engineering leadership, I am a force for continuous, measurable improvement. I am proudest of the projects that made the largest difference in my company’s performance.Key Strengths:✔ CONTINUOUS IMPROVEMENT – I constantly pursue the highest-impact opportunities to enhance our operation for greater efficiency, productivity, or profitability. At Surround Medical Systems, I transformed the entire quality assurance system into more innovative, leaner, and efficient. When these changes were complete, only two people could manage the entire QA function. ✔ START-UP OPERATIONS – Although I have valuable experience at established companies, my specialty is scaling fledgling start-up companies by building the infrastructure and connections they need to grow sustainably. At SunTech, I built our first facility in China on an accelerated timeline, multiplying our production capacity. ✔ PRACTICAL SOLUTIONS – With my wealth of hands-on experience, I bring a common-sense approach to problem-solving and persist when we encounter process roadblocks and other challenges. This allows me to prioritize the tasks and projects with the highest return on investment and carefully balance cost, time, and value in all decisions.
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Senior Vice President OperationsAdvanced Animal DiagnosticsChapel Hill, Nc, Us
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Vice President Of QualityScion Neurostim, Inc Nov 2023 - PresentDurham, North Carolina, Us -
Vice President Of Operations And QualitySurround Medical Systems, Inc. Jul 2021 - Dec 2023Guided the start-up company’s transition from R&D to commercial growth stage, requiring ground-up development of scalable production and quality infrastructure. Established production lines at the original facility and set up a second manufacturing facility from scratch. Key achievements: (1) developed bills of material (BOMs), inventory controls, and an ERP system; (2) migrated the quality management system (QMS) from 100% paper to 95% electronic; and (3) achieved compliance with FDA 21 CFR Part 820 and ISO 13485, which enabled sales activities in the U.S. and EU.
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Senior Vice President Of Engineering, Sales, And Supply ChainP1 Technologies (Formerly Plastics One) Jun 2020 - Oct 2020Roanoke, Virginia, UsIn this short-term change leadership engagement, led efforts to strengthen budgeting, forecasting, and financial reporting processes at the contract manufacturer. Key Achievements: (1) converted four batch flow production lines into Lean manufacturing cells, (2) introduced robotic automation that reduced head count, and (3) eliminated production defects. -
Vice President Of Quality And OperationsBaebies Mar 2018 - Jun 2020Durham, Nc, UsAs a member of the executive management team at this biotech start-up, oversaw the entire manufacturing operation, including strategies for quality, information technology, and safety management.Key Achievements: (1) reorganized in-house and contract management operations, which improved cost, quality, and delivery; (2) designed a sales and operations planning (S&OP) tool for forecasting and demand planning; implemented ERP and PLM systems; and (3) led process improvements that increased revenue by 60% and on-time delivery rate from 70% to 98%. -
Vice President Of Operations, Engineering, Quality/Regulatory, And Customer ServiceSuntech Medical Jan 2007 - Mar 2018Morrisville, North Carolina, UsOversaw manufacturing operations, engineering, global quality and regulatory affairs, and customer service operations in the U.S., China, and UK. Achieved 6% to 8% YoY COGS savings for seven consecutive years, which enabled the company to maintain 70% gross margin while reducing some product prices. Advanced steadily from Director to Vice President.Key Achievements: (1) established a facility in Shenzhen, (2) developed and transferred 20+ new products to manufacturing, (3) executed 16 continuous improvement initiatives, and (4) hosted 15+ training events in Kaizen, Lean Manufacturing, 5S, and safety improvement. -
Vice President Of Quality, Regulatory, And EngineeringSuntech Medical Jan 1999 - Jan 2007Morrisville, North Carolina, UsJoined as the 11th employee during start-up phase. Built and managed the entire quality system for U.S. and global standards. Led efforts to design, develop, and sell OEM blood pressure modules, which became the company’s most profitable product category. Oversaw five successful FDA audits, 20 ISO 13485 audits, and 50+ customer audits.Regulatory experience: FDA cGMP, ISO 13485, ISO 9001, ISO 14971, MDSAP, cGMP, 21 CFR 820, 21 CFR 822, 21 CFR 117, 21 CFR 801, IEC 62304, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-XX, IEC 60601-1-X, and IEC 60601.
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Director Of Quality And RegulatorySuntech Medical Jan 1996 - Jan 1999Morrisville, North Carolina, UsJoined as the 11th employee during start-up phase. Built and managed the entire quality system for U.S. and global standards. Wrote five 510k’s for FDA and CE marked 10+ products to the MDD (later to MDR).
David Gallick Skills
David Gallick Education Details
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University Of North Carolina WilmingtonGraduate Coursework (36 Of 48 Credits) Toward Master Of Business Administration (Mba) -
University Of North Carolina At CharlotteElectrical Engineering
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University Of North Carolina At CharlotteEconomics
Frequently Asked Questions about David Gallick
What company does David Gallick work for?
David Gallick works for Advanced Animal Diagnostics
What is David Gallick's role at the current company?
David Gallick's current role is Senior Vice President Operations.
What is David Gallick's email address?
David Gallick's email address is dg****@****ies.com
What is David Gallick's direct phone number?
David Gallick's direct phone number is +191965*****
What schools did David Gallick attend?
David Gallick attended University Of North Carolina Wilmington, University Of North Carolina At Charlotte, University Of North Carolina At Charlotte.
What skills is David Gallick known for?
David Gallick has skills like Medical Devices, Product Development, Iso 13485, Fda, Manufacturing, Process Improvement, Quality System, Product Management, Quality Assurance, Strategic Planning, Lean Manufacturing, R&d.
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