Kristen D'Uva Email and Phone Number
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Strategic leader who utilizes analytic rigor to solve complex problems and deliver essential organizational solutions. I'm a versatile visionary who has worked in all facets of Quality and thrive in the progression from discovery to phase appropriate GxP development to commercialization of products finding efficient solutions for quick approvals. I’m a forward-thinking professional respected for 25+ years orchestrating global quality strategy and ops for industry leaders. I drive continuous improvement and use innovation, rigorous analysis, and cutting-edge technologies to elevate profits and maximize performance. I establish and align pacesetting teams while managing up to $500MM+ budgets, 14 global sites, and hundreds of vendors. Additionally, I continue to achieve complete regulatory compliance for complex, international pharmaceutical and medical device requirements. By forging lasting stakeholder relationships, I enable C-level coordination and constantly deliver on long-term business objectives. My exceptional tenure includes numerous promotions. Product Experience: Small and Large molecule (Drugs, Biologics, & Vaccines & Devices) | Sterile and non-sterile | Intermediates | Drug Substance/API | Drug Product | Combination Products | Medical Devices – all classes Key areas of specialization:Quality Management/Assurance/Compliance | Executive Leadership | Policy Development | Strategic Planning | International Regulations (Bio)Pharmaceuticals, Medical Devices, combination products) | Continuous Improvement | Innovation | Visioning | Analytics, Metrics, KPIs | Team Building | Stakeholder Engagement | Emerging TechnologySelected highlights from my career:✔️Delivered 30+ successful regulatory inspections (FDA, MHRA, EMA, Health Canada, Anvisa, PMDA, TGA, etc.) throughout tenure for industry leaders. ✔️Utilized exceptional leadership abilities to implement a comprehensive quality system approach and drive compliance with all development and GxP operations while maintaining an efficient workflow to facilitate operational excellence at all sites.✔️Analyzed areas for improvement and optimized individual performance and group collaboration to significantly enhance overall department productivity and efficiency.✔️Improved methods for overseeing the development, implementation, and oversight of Quality Management Systems (QMSs), realizing complete global harmonization.✔️Commended by executive leadership for flawlessly coordinating and diligently performing 100+ audits at corporate headquarters involving 400+ active, high-profile clients.
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Vice President, Quality OperationsUnited Therapeutics CorporationChapel Hill, Nc, Us
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Senior Vice President, Quality And Regulatory Compliance HeadAvior Bio Inc. 2024 - Present• Led end-to-end Quality Assurance (QA), Quality Systems and Compliance (QS&C), and Quality Control (QC) operations, ensuring adherence to industry standards and global regulatory requirements.• Developed and implemented a phase-appropriate Quality Management System (QMS), including the deployment of electronic Document Management System (eDMS) and electronic Quality Management System (eQMS) platforms.• Oversaw Supplier Management, including the auditing program and Quality Technical Agreements (QTAs), to maintain high-quality standards across the supply chain.• Authored and enforced comprehensive company-wide Policies, Standard Operating Procedures (SOPs), Work Instructions (WIs), and Forms (FRMs) to standardize operations and ensure compliance. -
President And CeoMaven Quality Consulting, Llc 2000 - PresentMaven Quality Maven Quality Consulting, a distinguished firm in the pharmaceutical, biopharmaceutical, biotech, and medical device sectors, stands at the forefront of quality consulting. Our proficient team of specialists is dedicated to quality management, assurance, compliance, policy formulation, strategic delineation, and fostering stakeholder relationships. Through unwavering commitment to innovation, continuous enhancement, and the integration of cutting-edge technology, we empower our clients to realize their quality objectives effectively.Principal Quality Consultant During this period, I collaborated as a part-time consultant with diverse pharmaceutical companies, offering profound insights into quality and submission strategies. My contributions aided in enhancing the quality landscape and fostering effective submission tactics within the industry. -
Executive MemberChief 2022 - PresentNew York, Ny, UsChief is a private network built to drive more women into positions of power and keep them there. Chief is the only organization specifically designed for the most powerful women executives to strengthen their leadership, magnify their influence, and pave the way to bring others with them. -
Executive MemberWomen In Bio - Engage. Educate. Empower. 2023 - PresentPittsburgh, Pa, UsWomen In Bio is an organization of professionals committed to promoting careers, leadership, and entrepreneurship for all women in the life sciences. -
Vice President, Global Quality OperationsCuria (Formerly Amri) 2019 - 2023Albany, Ny, UsCuria is a International Contract Development and Manufacturing Organization (CDMO) with over 30 years of experience. Curia's biologics and small molecule offering spans discovery through commercialization, with integrated regulatory and analytical capabilities. At Curia, I Lead the Global R&D Quality Unit for the Discovery, Development, Analytical, Fine Chemical, and Early Phase through commercial Manufacturing Business Units♦ Spearheaded the global R&D quality unit for the discovery, development, analytical, fine chemical, and early phase manufacturing through validation/commercial, contributing to a 65% quality improvement and increasing business performance while ensuring compliance. ♦ Engaged cross-functional senior leadership in establishing and maintaining a risk-based and scientific-based quality system to assure compliance and meet crucial business needs. Developed Quality strategies to enhance the value to the organization and create new opportunities for improving profits. -
Global Head Of Quality | Senior Director, Global Quality AssuranceCircassia Usa Oct 2017 - Dec 2019Morrisville, North Carolina, UsCircassia is the world leader in respiratory medical devices and combination products / drugs. At Circassia I was the Global Head of Quality |Senior Director, Global Quality Assurance.Ensured all cGxP work is completed in compliance with applicable regulations and standards. Managed the entire Quality System on a global basis for all internal systems and external supplier oversight.♦ Position holding increasing authority and responsibility due to exemplary performance and strong management abilities while expanding business. ♦ Oversaw all aspects of the global quality system for a specialty pharmaceutical and medical device company. ♦ Managed the entire quality system globally for all internal systems and supplier oversight and maintained a large global budget with 25% cost savings/avoidance. -
Asc Dir/Dir Of Quality AssuranceBiodelivery Sciences International Inc (Bd5) Dec 2014 - Oct 2017BioDelivery Sciences is a specialty pharmaceutical company that focused on unmet medical needs with novel delivery systems. At BDSI I oversaw the Quality System for a specialty pharmaceutical company with proprietary drug delivery. Ensured all cGxP work is completed at contractor sites in compliance with applicable guidelines and regulations, including the Code of Federal Regulations, and other applicable FDA, ICH, EMA, and DEA requirements. ♦ Led new product quality support, regulatory submissions' CMC data, QA's GxP documentation filing system, and project oversight from formulation to GLP studies to ensure a quality clinical outcome.♦ Selected to manage the quality management system's comprehensive development, implementation, and oversight, delivering results to exceed all expectations.♦ Accomplished product approval from FDA, utilizing best practices to optimize costs and retain superior quality.♦ Prepared and maintained quality reports, summaries, trend data, master and executed production batch records, validation protocols, stability protocols, specifications, change controls, SOPs, APRs, complaints, and deviations/investigations and released all materials and product authorizations to clinics/markets.
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Quality Assurance Compliance ManagementBaxano Surgical (Formerly Trans1) May 2012 - Nov 2014Magnolia, Texas, UsBaxano Surgical (TranS1) has designed, developed, and commercialized transformational approaches to the spine used by thousands of surgeons to minimize the damage associated with traditional surgical approaches. At BAXS I oversaw the entire Quality Management System (QMS) for a global medical device company specializing in minimally invasive surgical technologies. Coordinated, conducted and managed the Management Review Process including semi-annual meetings and interim reporting requirements. ♦ Drove stellar results as the system owner for Corrective and Preventive Action (CAPA), Customer Complaint System, Document Control, Internal/External Audit Program, external contract manufacturers, supplier management, and external agencies inspection team leading to four successful US FDA and ISO audits.♦ Improved methods to manage the development, implementation, and oversight of the Quality Management System (QMS) compliant with 21 CFR Part 820, EU MDD, CA MDR, and ISO 13485 through the complete harmonization of the entire QMS with all business units. -
Corporate Quality Assurance ManagementAaipharma Nov 2005 - Apr 2012Wilmington, Nc, UsAAIPharma is a international contract development, testing, and manufacturing organization for pharma and biotech companies as well as provide CMO services for clinical trials. At AAI I provided Corporate Quality Assurance support to a global provider of product development, manufacturing and support services to the pharmaceutical, biotechnology, and medical device industries worldwide (sterile and non-sterile products). ♦ Promoted due to superb attention to detail, flawlessly coordinating and diligently performing 100+ audits at corporate headquarters involving 400+ active, high-profile clients.♦ Led 16 successful regulatory audits by U.S. Food and Drug Administration (FDA), The Medical Products Agency (MPA), Medicines and Healthcare products Regulatory Agency (MHRA), Irish Medicines Board (IMB), and The European Medicines Agency (EMA - formerly the EMEA) regulatory audits. -
Quality And Compliance For Pharmaceutical Production (Solid-Dose)Aaipharma Jun 2004 - Nov 2005Wilmington, Nc, UsProvided Quality and Compliance support in all stages of pharmaceutical manufacturing from Clinical to Commercial. ♦ Delivered full quality and compliance support in all stages of pharmaceutical manufacturing, from clinical to commercial, including performing quality reviews and approval of all production batch records, raw materials, and components.♦ Monitored production processes and performed AQLs for manufacturing, packaging, and distribution to assure compliance and effectiveness.
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Compliance Review Specialist / Batch Release For Pharmaceutical Production (Mainly Sterile Products)Dsm Jul 2002 - May 2004Heerlen, Limburg, NlFull-service international CDMO to the pharmaceutical and biotech industry. At DSM I provided direct cGMP support to the Steriles and Orals & Topicals clinical and commercial production units, and Company Corporate Management. Led/performed investigation and evaluation of all components within batch record documentation. Performed Batch Release. Member of Six Sigma and Lean manufacturing team.♦ Proactively networked with Production Management, Quality Executive Management and Laboratory Management to determine assignable cause, preventative measures, and response to clients and regulatory authorities.♦ Identified areas of non-compliance, reviewed recommendations, and implemented solutions, including design and implementation of innovative new software programs to improve compliance and efficiency of all business units.♦ Trained and supervised subordinate Compliance Review Specialists to meet and rise above all corporate objectives. -
Quality Control Scientist (Microbiology)Dsm Apr 2000 - Jul 2002Heerlen, Limburg, NlPerformed microbiological plate/microbiological turbidimetric assay. Performed anti-factor assays, growth promotion studies, and in-house culture preparations. Participant in remediation team. Team member of LIMS implementation and sample bar-coding.♦ Interpreted complex data and clearly, concisely reported all results in the appropriate database. ♦ Performed extensive mapping studies for environmental monitoring, ensuring FDA guideline/internal conformance.♦ Essential member of Computer System Database Process Improvement Team and performed the migration of all GMP data to protected folders and systems to comply with Title 21 CFR Part 11 - Electronic Records/Signatures.
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Sterile Product FacilityGlaxowellcome 1995 - 1999Brentford, Middlesex, GbGSK is a global fine chemical, heathcare, drug and biopharma company with a purpose to unite science, technology and talent to get ahead of disease.Sterile Products Operations Oversight Primary duties included:♦ Supported the launch of a new state of the art sterile facility supporting cross-functional teams. ♦ Developed, designed and implemented a Generic Packaging Work Order system for each of the production/packaging lines in the Sterile Products Facility. Creation of additional procedures as needed and compiled filing forms for managers;♦ Analyzed and revised Standard Operating Procedures;♦ Audited and rectified existing filling and packaging work orders for products before presenting to Quality Assurance for final release. -
Principal Environmental/Managerial Consultant | 1990 - 1999Freelance 1990 - 1999Operating in a part-time and flexible capacity, I held the role of Principal Environmental/Managerial Consultant. My responsibilities encompassed a comprehensive managerial spectrum, spanning task delegation, scheduling, supervision, procurement, testing, and financial analysis. This partnership with store proprietors revolved around maintaining aseptic environmental conditions and producing meticulous reports, underscoring my proficiency in both environmental stewardship and business acumen.
Kristen D'Uva Skills
Kristen D'Uva Education Details
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East Carolina UniversityBiology -
Northeastern UniversityBusiness Finance
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University Of Rhode IslandCivil & Ocean Engineering
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IcsWildlife And Forestry Conservation And Management
Frequently Asked Questions about Kristen D'Uva
What company does Kristen D'Uva work for?
Kristen D'Uva works for United Therapeutics Corporation
What is Kristen D'Uva's role at the current company?
Kristen D'Uva's current role is Vice President, Quality Operations.
What is Kristen D'Uva's email address?
Kristen D'Uva's email address is kr****@****bal.com
What is Kristen D'Uva's direct phone number?
Kristen D'Uva's direct phone number is (910)-254*****
What schools did Kristen D'Uva attend?
Kristen D'Uva attended East Carolina University, Northeastern University, University Of Rhode Island, Ics.
What skills is Kristen D'Uva known for?
Kristen D'Uva has skills like Fda, Gmp, Capa, Quality System, Sop, Quality Assurance, Pharmaceutical Industry, Medical Devices, Quality Auditing, Biotechnology, Quality Control, 21 Cfr Part 11.
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