Kristen D'Uva Email & Phone Number

Chapel Hill, NC, US

• 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.

Maven 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.

New York, NY, US

Chief 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.

Pittsburgh, PA, US

Women In Bio is an organization of professionals committed to promoting careers, leadership, and entrepreneurship for all women in the life sciences.

Albany, NY, US

Curia 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.

Morrisville, North Carolina, US

Circassia 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.

BioDelivery 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.

Magnolia, Texas, US

Baxano 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.

Wilmington, NC, US

AAIPharma 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.

Wilmington, NC, US

Provided 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.♦.

Heerlen, Limburg, NL

Full-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.

Heerlen, Limburg, NL

Performed 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. ♦.

Brentford, Middlesex, GB

GSK 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.

Operating 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.

Bsc Ms, Biology

Bsc, Business Finance

Bsc, Civil & Ocean Engineering

Aasc, Wildlife And Forestry Conservation And Management