Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Accomplished Global Director of Quality Assurance with over 25 years of expertise in quality management, regulatory affairs, and commercialization of combination products and medical devices. Proven track record of managing quality assurance teams and driving compliance with FDA, ISO, and other global regulatory standards in the medical device and pharmaceutical industries. Expertise in drug delivery platforms (injectables, prefilled syringes, autoinjectors, electro-mechanical on-body delivery systems), Asthma inhalers, single-entity, co-packed, and cross-labeled combination products, laparoscopic devices, transcatheter heart valves, and drug-eluting stents. Proficient in regulatory frameworks, including ICH Q8-Q10, ICH E6(R2), and 21CFR Parts 4, 210/211, 803, 806, and 820. Bilingual in English and Spanish.

CORE COMPETENCIES

  • Clinical Trial Quality Assurance
  • Clinical Evaluation Plans/Reports
  • Regulatory Compliance (FDA, ISO)
  • Quality Management Systems (QMS)
  • Risk Management & FMEA
  • Process Development & Improvement
  • CAPA, Change Control & Remediation
  • Inspection Readiness for US and EU
  • Auditing & Inspections
  • Analytical Method Development and Validation
  • Regulatory Submissions (INDs/BLAs/PMAs)
  • Post-Market Surveillance
  • Clinical Operations (GMP/GCP/GVP)
  • Medical Devices and Combination Products
  • Supplier Quality & Vendor Qualification
  • Cross-Functional Leadership & Team Management
  • Lean Six Sigma Methodologies
  • Design Control & Validation

SELECTED ACCOMPLISHMENTS

  • Cost Reduction and Lab Establishment: Led the initiative to establish, validate, and launch two internal labs for medical devices, adhering to FDA, EU, and ISO 13485 standards, saving $3M annually by reducing reliance on external testing facilities and minimizing poor quality costs.
  • Global Compliance Improvement: Implemented and monitored quality management systems across global teams, achieving a 95% compliance rate with FDA and cGMP regulations, improving operational efficiency and audit readiness.
  • Risk Mitigation Strategy Implementation: Spearheaded the creation of a Quality Risk Assessment framework, resulting in early identification of product risks and successful risk mitigation strategies, reducing deviations and CAPAs by 40%.
  • GR&R Protocol Optimization: Achieved a $500K annual cost reduction by optimizing GR&R protocols for the measurement of tissue leaflets in heart valves, improving product reliability and decreasing production costs.
  • Customer Complaint Reduction: Implemented iterative design changes for Enbrel legacy combination products, reducing unresolved customer complaints by 30% and improving product safety and user satisfaction.

PROFESSIONAL EXPERIENCE

  • Precision Regulatory Consulting LLC – Founder (Aug 2016 – Present)
    • Developed and executed regulatory strategies for medical devices and biotech industries, resulting in the successful submission of 5 INDs and 3 BLAs.
    • Supported clients in regulatory filings, product development, and audit readiness, focusing on GCP, GMP, and GLP compliance.
    • Advised clients on complex regulatory compliance issues, resulting in a 15% increase in client satisfaction scores.
  • Alexion Pharmaceuticals (AstraZeneca Rare Disease Unit) – Director, Corporate Clinical Product Quality (April 2020 – July 2024)
    • Managed global regulatory and quality strategies for biologics, medical devices, and combination products, aligning with cGMP standards.
    • Achieved 95% compliance in regulatory reporting and implemented quality frameworks that saved $3M through lab setup.
    • Ensured up-to-date regulatory intelligence, reducing device compliance risks by 50%.
  • Alexion Pharmaceuticals – Director, R&D Quality / Expert Consultant (Sept 2019 – April 2020)
    • Developed EU MDR procedures and launched compliance courses for injectable combination products, contributing to IND and BLA approvals.
    • Led Device Quality Operations with oversight of GMP, GVP, and GCP for combination products.
  • Merck & Co. – Director, Global QA – Devices and Combination Products (Feb 2017 – Aug 2019)
    • Directed global QA/RA strategies for vaccines and combination products, resulting in the successful launches of Gardasil 9® and Pneumovax 23.
    • Planned and executed DHF remediation efforts for 32 products, achieving FDA and ISO13485 compliance.
  • Noven Pharmaceuticals – Director of Quality Engineering (Jul 2014 – Nov 2016)
    • Managed quality engineering, validation, and Lean Sigma training, overseeing the timely remediation of FDA 483 observations and improving audit outcomes.
  • Amgen – Principal Device Quality Engineer (May 2012 – Jul 2014)
    • Led quality assurance for injectable products, achieving zero observations during FDA audits for Neulasta® and Repatha® launches.
    • Reduced unresolved customer complaints by 30% for Enbrel legacy combination products through iterative design changes.

EDUCATION

  • Master of Science (MS) in Regulatory Affairs Science – San Diego State University, CA (May 2016)
  • Master of Business Administration (MBA) in Global Management – University of Phoenix, Plantation, FL (June 2022)
  • Bachelor of Science (BS) in Chemistry – Florida International University, Miami, FL (May 1997)
  • Associate of Arts (AA) in Biology – Miami Dade College, Miami, FL (June 1993)

CERTIFICATION

  • Certified Six Sigma Black Belt (CSSBB) – American Society for Quality (ASQ)
  • Certified Quality Engineer (CQE) – ASQ
  • Biomedical Auditor (CBA) – ASQ
  • Certified Manager of Quality of Organizational Excellence (CMQ/OE) – ASQ
  • EU Medical Device Regulation (EU MDR) Certified – MEDDEV

TRAINING

  • Statistical Methods for Quality Engineering” by Consulting Alliance Group
  • “Design Control and Risk Management for Medical Device Industry” by Excel Partnership (Aug 2006)
  • Certified Lean Sigma Black Belt at Medtronic and Johnson & Johnson (Jun 2008)
  • “EU Medical Device Regulation (EU MDR)” by MEDDEV Solutions (Feb 2017)

AFFILIATIONS

  • American Society for Quality (ASQ)
  • Regulatory Affairs Professionals Society (RAPS)
  • Parenteral Drug Association (PDA)
  • International Society for Pharmaceutical Engineering (ISPE)

PUBLICATIONS AND PRESENTATIONS

  • Vanegas, L. (2019). How Can Quality Help Drug-Device Teams Become Agile? Presented at 9th Ed. Injectables Summit, San Diego.
  • Vanegas, L. (2020). How Quality Can Help Drug-Device Combination Teams Become Agile in Changing Regulatory Environment. Presented at Pre-filled Syringes East Coast Virtual Conference, SMi.
  • Vanegas, L. (2022). Practical Applications of a Streamline Approach (21CFR part 4 – Subpart A) cGMPs of CPs in Pharma. Presented at 12th Edition Injectables Summit, Boston, MA.
  • Vanegas, L. (2024). Test Method Validation Strategies of Prefilled Syringes. Presented in Boston, MA.