Christina Siniscalchi
Chief Quality Officer leading quality strategy and regulatory compliance.
- Role
- Chief Quality Officer at Alvogen
- Location
- Norwich, NY, US
- LinkedIn followers
- 500 followers
About Christina Siniscalchi
At the helm of Alvotech\'s global quality initiatives, the focus has been on robust strategic planning and execution, underscored by a successful first commercial FDA inspection and a significant overhaul of quality processes. The organization has achieved a 76% reduction in batch record backlog and a 65% decrease in open deviations, demonstrating a strong commitment to product safety and regulatory adherence.Leading with a detail-oriented and problem-solving approach, our team has realized an 80% improvement in disposition cycle time and fully implemented eQMS & LIMS, enhancing operational efficiency and compliance. These accomplishments stem from a dedication to fostering collaborative environments that align with the company\'s mission and regulatory expectations, ensuring Alvotech\'s position as a frontrunner in the biosimilars and biologics fields.
Experience
Chief Quality Officer
Nov 2023 — Present · Morristown, NJ, US
Oversaw all Quality and Pharmacovigilance systems at Alvogen, ensuring compliance and efficiency.• Led diverse portfolio oversight, including sterile, solid oral dose, inhalational, and combination drug/device products.• Implemented strategic quality initiatives to drive continuous improvement and regulatory compliance.
Education
Temple University
Master of Science - MS, Regulatory Affairs and Quality Assurance
2016 — 2020
Georgia Institute of Technology
Bachelor of Science (BS), Applied Biology
1994 — 1998
Skills
- Pharmaceutical Industry
- Sop
- Fda
- Cgmp Practices
- Dissolution
- Continuous Improvement
- Clinical Trials
- Analytical Chemistry
- Quality Management
- U.s. Title 21 Cfr Part 11 Regulation
- Hplc
- Cleaning Validation
- Capa
- Change Control
- Chromatography
- Biotechnology
- Glp
- Usp
- Iso 13485
- Uv/Vis
- U.s. Food and Drug Administration (Fda)
- Quality Control
- Gmp
- Quality System
- V&V
- Deviations
- 21 Cfr Part 11
- Contract Manufacturing
- Corrective and Preventive Action (Capa)
- Regulatory Affairs
- Computer System Validation
- Quality Assurance
- Gamp
- Root Cause Analysis
- Validation
- Drug Development
- Fda Gmp
- Lims
- Regulatory Requirements
- Gxp
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