Nadine Wolday
Miami Beach,FL
Summary
Accomplished life sciences professional with advanced expertise in biomanufacturing science, quality systems engineering, and regulatory compliance strategy. Experienced in GMP production, process optimization, and analytical data interpretation across clinical stage to large scale commercial environments. Proven ability to design, implement, and scale Quality Management Systems (QMS) that integrate scientific rigor with operational excellence, ensuring full compliance with FDA, ISO, and ICH guidelines. Skilled in translating complex experimental and process data into actionable quality insights to drive risk mitigation, process consistency, and audit readiness. Recognized for effectively bridging R&D, process development, manufacturing, and regulatory affairs to deliver data driven, compliant, and high quality biopharmaceutical solutions.
Overview
7
7
years of professional experience
Work History
Quality Assurance Specialist
Transpire Bio
02.2024 - Current
- Quality Systems Management/ Regulatory & Compliance/ Doc control
- Partnered with R&D and process development teams to evaluate data from stability studies and formulation trials, ensuring documentation aligned with clinical and regulatory standards.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Supported technical data review for late stage development programs, integrating scientific findings into controlled documentation and submission materials.
- Exercised full ownership and oversight of all controlled documentation across the organization, ensuring complete compliance with FDA, ISO, and GxP regulatory standards.
- Functioned as the central authority for document governance, overseeing creation, revision, approval, and archival processes for SOPs, batch records, policies, and controlled forms.
- Directed vendor and supplier qualification, due diligence, and quality agreement development ensuring all external partners met corporate and regulatory compliance requirements.
- Authored and standardized quality agreement templates and controlled document structures, creating uniformity across cross functional operations and accelerating approval timelines.
- Managed and validated the preparation, digitization, and submission of controlled documentation for regulatory filings and clinical trial support, ensuring accuracy, traceability, and data integrity throughout the submission lifecycle.
- Partnered closely with late stage manufacturing, regulatory affairs, and clinical operations to ensure all documentation and vendor data met submission and inspection readiness standards.
- Directed the company’s training and competency program, maintaining and creating comprehensive electronic training records and ensuring organization-wide adherence to qualification requirements.
- Managed CAPA, change control, and internal audit activities, strengthening QMS maturity and ensuring sustained audit readiness.
- Played a key role in establishing TranspireBio’s foundational Quality Management System (QMS) and compliance framework, positioning the company for late-stage development and pre-commercial operations.
- TranspireBio is a clinical stage biopharmaceutical startup focused on the development and commercialization of inhaled therapies for serious respiratory diseases.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
Biotech Production Specialist
Regeneron
05.2022 - 02.2024
- Conducted upstream bioprocess operations for monoclonal antibody production, operating 50 L–2000 L bioreactors under GMP/GMP conditions.
- Monitored cell growth kinetics, media formulation, and process parameters to maintain optimal culture conditions and achieve product purity > 99.5%.
- Supported technology transfer and scale-up activities, collaborating with Process Development, MSAT, and Engineering teams to enhance production efficiency and process robustness.
- Documented deviations in procedures or appearance on production batch sheets for management review.
- Performed real-time process data analysis using LIMS and MES, identifying optimization opportunities that improved yield and reduced variability.
- Partnered with Quality, Validation, and Regulatory groups to align production data with batch release and inspection requirements.
- Executed aseptic sampling and environmental monitoring, ensuring contamination control and compliance with regulatory standards.
- Trained and mentored 20 + production associates in GMP operations, aseptic technique, and data-driven troubleshooting.
- Renowned biopharmaceutical innovator recognized for pioneering large scale monoclonal antibody production and advanced GMP operations.
- Upstream Bioprocessing (GMP)
- Monitored production line for unsafe behaviors or incorrect techniques and worked with managers to resolve problems.
Medical Assistant
Nuvo You
10.2018 - 11.2021
- Collected and documented patient information and medical histories.
- Managed specimen handling, labeling, and lab courier coordination.
- Maintained accurate treatment and procedure records.
- Ensured cleanliness, sterilization, and safety standards were met.
- Supported daily clinic operations and inventory management.
- Educated patients on post-treatment care and recovery.
- Clinical aesthetics practice combining medical grade cosmetic procedures with patient care and treatment precision.
- Assisted with cosmetic procedures and patient preparation.
- Directed patients to exam rooms, fielded questions, and prepared for physician examinations.
Education
Bachelor of Arts - Psychology/Medical Science Track
Florida International University
Miami, Florida05-2022
Skills
- LABORATORY & SCIENTIFIC TECHNIQUES
- QUALITY & COMPLIANCE
- DATA & ANALYSIS TOOLS
- PROFESSIONAL & ANALYTICAL SKILLS
Timeline
Quality Assurance Specialist
Transpire Bio
02.2024 - Current
Biotech Production Specialist
Regeneron
05.2022 - 02.2024
Medical Assistant
Nuvo You
10.2018 - 11.2021
Bachelor of Arts - Psychology/Medical Science Track
Florida International University