Maria Micalizzi Conklin

About Maria Micalizzi Conklin

Strategic and execution-focused Quality Assurance leader with 20+ years supporting global GxP operations for clinical development of small molecules and biologics. Expert in GMP oversight of drug substance and drug product manufacturing, packaging, labeling, release, and distribution across all clinical phases. Proven success building and leading inspection-ready Quality Systems, managing CMOs/CDMOs, reviewing regulatory filings, and ensuring uninterrupted product supply. Recognized for strong cross-functional leadership, early risk identification, and ability to deliver compliant outcomes under accelerated timelines. Known as a highly adaptable leader who quickly acquires new skills and roles to ensure project success.Core Technical and Leadership Competencies:•Exceptional attention to detail with a track record of delivering high-accuracy, inspection-ready documentation.•Strong project and time management skills; able to manage multiple complex programs simultaneously.•Lead and delegate QA review and authorship contributions for regulatory submissions including IND, IMPD, NDA, sNDA, and MAA.•Deep understanding of QP declaration and EU release requirements, including AP release for IL.•Hands-on experience supporting clinical GMP manufacturing from starting materials through labeling and release for global regions.•Skilled at coordinating cross-functional reviews for regulatory filings including CSRs, DSURs, PADERs, INDs, IMPDs, NDAs, and sNDAs.•Lead inspection readiness activities across clinical operations, data management, pharmacovigilance, medical writing, and biostatistics.•Served as Back Room Manager for multiple FDA and EMA inspections; ensured rapid, accurate fulfillment of inspector requests.•Advanced knowledge of GMP, GLP, EMA, FDA, and ICH regulations and quality expectations.•Analytical method development and characterization expertise for small molecules using LC, LC/MS, GC, Karl Fischer, NMR, DSC/TGA, and dissolution.•Certified Veeva Platform Administrator; proficient in SmartSheet.

Experience

1. Senior Quality Assurance Consultant

   White-Salters Consulting, Llc

   Sep 2023 — Present

Education

• Boston University

  Bachelor's, Chemistry

  1991 — 1995

• Fitchburg State University

  Business Certificate, Business

  2003 — 2004

• Northeastern University

  Master of Science, Chemistry

  1997 — 2001

Skills

• Organic Synthesis
• Cgmp
• Biotechnology
• Pharmaceutical Industry
• Sop
• Fda
• High-Performance Liquid Chromatography (Hplc)
• Quality Control
• Gmp
• Standard Operating Procedure (Sop)
• Nmr
• Validation
• Chromatography
• Pharmaceuticals
• Ind
• Analytical Chemistry
• Product Development
• Organic Chemistry
• Hplc
• Protein Chemistry
• Liquid Chromatography-Mass Spectrometry (Lc-Ms)
• U.s. Food and Drug Administration (Fda)
• Lc-Ms
• Life Sciences