Open to opportunities

Christina Zeno

@christinazeno

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GMP quality and regulatory leader with 12+ years optimizing compliance, supply chain, and product lifecycle.

United States

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What I'm looking for

I seek senior roles leading quality and regulatory systems in biotech/pharma where I can drive inspection readiness, streamline QMS, mentor teams, and scale compliant supply operations.

I am a GMP quality and regulatory leader with over 12 years of experience across biopharma, clinical supply, and regulated operations. I blend deep expertise in quality assurance, regulatory compliance, and supply chain management with a marketing-driven perspective to launch and sustain products.

At Duke's MC3 and DHVI I led inspection-readiness programs, harmonized QMS processes across departments, and implemented digital toolkits and ELMS that reduced deviations and human error while improving audit readiness. I have overseen vendor and partner compliance for FDA-regulated biologics and supported CTM and submission alignment.

Earlier roles at Bristol Myers Squibb and Supernus sharpened my analytical and method-transfer capabilities, and I built predictive models and cost-saving initiatives that materially improved stability outcomes and lab OPEX. I regularly develop KPI dashboards and reporting frameworks to drive data-informed decision-making.

I mentor teams, design scalable training curricula, and drive process optimization to improve regulatory alignment and operational efficiency. I seek roles where I can lead quality systems, enable inspection readiness, and scale robust processes across cross-functional organizations.

Experience

Work history, roles, and key accomplishments

Quality Associate – Compliance Lead

Marcus Center for Cellular Cures

Oct 2023 - Jul 2025 (1 year 9 months)

Directed inspection-readiness planning and digital toolkit deployment, oversaw vendor compliance for two FDA-approved biologics through 19 on-site audits and 56 quality agreements with no major observations, and harmonized QMS processes across five departments to improve regulatory alignment and decision-making.

FDA 21 CFR Part 11 ISO 13485 Vendor Management CAPA

MBA Consultant – Marketing

UNC Kenan-Flagler Star Consulting

Jan 2025 - Jun 2025 (5 months)

Partnered with stakeholders to map product adoption and distribution readiness, designed a scalable 3-tier training curriculum and digital workflows that improved operational consistency and produced a 12% script lift in a pilot region.

Process Improvement Data Integrity Stakeholder Management Go To Market

Quality Associate – QA & LIMS Stability

Duke Human Vaccine Institute

Sep 2019 - Oct 2023 (4 years 1 month)

Redesigned the product stability program and integrated a $350K ELMS, reducing deviations 25% and human error 45%, managed outsourced testing and shipments for clinical studies, and implemented labeling for lot traceability with a 30% faster turnaround.

Elm LIMS GxP Labeling Supplier Management Regulatory Compliance

Senior Scientist – Analytical Transfer

Bristol Myers Squibb

Jan 2017 - Oct 2018 (1 year 9 months)

Authored six analytical method qualifications and three method transfers for global programs and trained a five-person scientific team in under two weeks to ensure study initiation and operational continuity.

Method Transfer laboratory operations Documentation Quality Assurance

Scientist – Analytical Strategy

Supernus Pharmaceuticals

Feb 2013 - Aug 2016 (3 years 6 months)

Built an R-based predictive model that reduced stability failures 33% saving $250K/year, led reagent procurement negotiations achieving 15% cost reduction, and supported stability programs and IND submissions for oral solid dosage forms.

R Stability Testing Procurement IND