Michael Schwartz
GxP QA Executive | Biologics/Cell&Gene Therapy | Small Molecule | Viral | mRNA+LNP and Combination Products Phase I-III to Commercial | Focused on Oncology, Rare Diseases, Autoimmune diseases | GxP Auditor |
- Role
- Head of Quality Assurance at Orna Therapeutics
- Location
- Chelmsford, MA, US
- LinkedIn followers
- 500 followers
About Michael Schwartz
Dynamic and results-driven Quality Compliance Executive with polyvalent Good…
Experience
Head of Quality Assurance
Jan 2022 — Present · Watertown, MA, US
Spearheaded the Quality Assurance team for Phase I mRNA product pipeline for targeted oncology therapies · Implementing the GxP Quality Management System (Good Laboratory, Clinical, and Manufacturing Practices) · Customer Relationship Management/set up all Quality Agreements for CDMO oversight for Investigational Product · Developed comprehensive training programs for entire site preparing for GxP Inspection Readiness and Regulatory Compliance · Championed continuous process improvement initiatives, streamlining internal workflows and effective quality-related cycle times
Skills
- Ctms
- Regulatory Affairs
- Lifesciences
- Design Control
- Technology Transfer
- Gxp
- Quality Auditing
- Aseptic Processing
- Validation
- U.s. Title 21 Cfr Part 11 Regulation
- CRO
- Pharmacovigilance
- Pharmaceutical Industry
- Sop
- Fda
- CRO Management
- Gmp
- Good Clinical Practice (Gcp)
- Medical Devices
- Capa
- Clinical Development
- Fmea
- Oncology
- Regulatory Requirements
- Ind
- U.s. Food and Drug Administration (Fda)
- Quality Assurance
- Glp
- Quality System
- V&V
- Clinical Trials
- Change Control
- Vaccines
- Drug Development
- Gcp
- Biopharmaceuticals
- Regulatory Submissions
- 21 Cfr Part 11
- Computer System Validation
- Iso 13485
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