Melissa Schroeter
Director Quality Systems at International AIDS Vaccine Initiative (IAVI) | Pearl River, New York, United States
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Melissa Schroeter serves as the Director of Quality Systems at the International AIDS Vaccine Initiative (IAVI), where she leverages her extensive expertise in drug development and regulatory compliance to drive innovative solutions in the biopharmaceutical sector. With a robust background that encompasses all phases of drug development, Melissa plays a pivotal role in ensuring that IAVI's projects adhere to stringent FDA regulations and Good Manufacturing Practices (GMP). Her legal acumen enhances her ability to liaise effectively with scientific teams, fostering a culture of compliance that is essential for maintaining the integrity of research and development efforts.
In her current role, Melissa is instrumental in the operational coordination of regulatory submissions for early-phase projects, guiding her team through the complexities of regulatory landscapes. Her experience in planning for inspections by government agencies and corporate audits ensures that IAVI is always prepared to meet the highest standards of quality and safety. Melissa's expertise in validation, change control, and the disposition of materials is critical in advancing IAVI's mission to develop effective vaccines against HIV and other infectious diseases.
Key projects under her leadership include the implementation of robust quality management systems that streamline processes and enhance efficiency, ultimately accelerating the path from research to clinical trials. With a strong focus on technology transfer and internal audits, Melissa is dedicated to fostering a culture of continuous improvement within the organization. Her multifaceted skill set, including knowledge of Good Laboratory Practices (GLP) and new product validation, positions her as a vital asset in the pursuit of groundbreaking advancements in the biopharmaceutical industry.
Director Quality Systems at International AIDS Vaccine Initiative (IAVI) in March 2019 to Present
Regulatory Affairs Manager at International AIDS Vaccine Initiative (IAVI) in January 2015 to March 2019
Consultant Regulatory Affairs at International AIDS Vaccine Initiative (IAVI) in September 2014 to December 2014
QSC Investigator at Novartis in July 2013 to March 2014
Sr. GMP Specialist - Generic Products at Endo Pharmaceuticals in June 2011 to February 2013
Associate Director/Manager/Research Scientist III at Pfizer (Wyeth) in March 1996 to June 2011
Clinical Supply Tech/Toxicology Tech/Research Scientist I & II at Pfizer (Wyeth) in February 1989 to February 1996
Undergraduate Research Assistant at SUNY Plattsburgh in January 1986 to December 1987
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FDA
Toxicology
GMP
Validation
GLP
R&D
Pharmaceutical Industry
Pharmaceutics
Quality System
Formulation
Clinical Trials
IND
GCP
Analytical Chemistry
Quality Assurance
Sop
Technology Transfer
Drug Development
Regulations
Regulatory Requirements
Regulatory Analysis
Internal Audit
Quality Auditing
External Audit
Legal Issues
Legal Advice
Legal Compliance
Regulatory Affairs
New Product Validation
Cleaning Validation
Computer System Validation
Research Ethics
Professional Ethics
Legal Ethics
Medical Ethics
Administrative Law
Microbiology
Aseptic Processing
Aseptic Technique
Policy Analysis
Clinical Research
Risk Management
Risk Assessment
Risk Analysis
Biopharmaceuticals
Negotiation
Dependable Team Player
Team-oriented
Writing
Biotechnology
Project Management
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What is Melissa Schroeter email address?
Email Melissa Schroeter at [email protected] and [email protected]. This email is the most updated Melissa Schroeter email found in 2026.
What is Melissa Schroeter phone number?
Melissa Schroeter phone number is +18457094414.
How to contact Melissa Schroeter?
To contact Melissa Schroeter send an email to [email protected] or [email protected]. If you want to call Melissa Schroeter try calling on +18457094414. (updated on September 13, 2024)
What is Melissa Schroeter net worth?
Melissa Schroeter has an estimated net worth of $375,000 to $499,999
What company does Melissa Schroeter work for?
Melissa Schroeter works for International AIDS Vaccine Initiative (IAVI)
What is Melissa Schroeter's role at International AIDS Vaccine Initiative (IAVI)?
Melissa Schroeter is Director Quality Systems
What industry does Melissa Schroeter work in?
Melissa Schroeter works in the Research Services industry.
Melissa Schroeter Email Addresses
Melissa Schroeter Phone Numbers
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