Paula Lee, M.S.

Paula Lee, M.S. Email and Phone Number

Associate Director, QA Operations Commercial Lead @Sage Therapeutics | GMP System Design and Validation, Packaging Process Validation, Commercial Product Launch, Continuous Improvement, CMC @ Sage Therapeutics
Paula Lee, M.S.'s Location
Greater Boston, United States, United States
Paula Lee, M.S.'s Contact Details

Paula Lee, M.S. work email

Paula Lee, M.S. personal email

n/a

Paula Lee, M.S. phone numbers

About Paula Lee, M.S.

A stewardship in quality assurance and quality control defines my commitment to excellence in the biopharmaceutical industry. With a proven track record in managing QA operations for both clinical and commercial stages, my focus is on upholding rigorous quality systems and compliance with FDA regulations. The recent years have been marked by the successful quality management of drug substance, drug product, and packaged finished products, ensuring the highest standards for patients.Collaboration and strategic thinking are the cornerstones of my approach to navigating complex challenges within a dynamic work environment. At Sage, I fostered a culture of innovation where the development of effective solutions is paramount. Through cross-functional teamwork, I enhanced QA oversight for quality control and contract testing labs, supporting CMC development programs and commercial operations with an unwavering commitment to quality and patient safety.

Paula Lee, M.S.'s Current Company Details
Sage Therapeutics

Sage Therapeutics

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Associate Director, QA Operations Commercial Lead @Sage Therapeutics | GMP System Design and Validation, Packaging Process Validation, Commercial Product Launch, Continuous Improvement, CMC
Paula Lee, M.S. Work Experience Details
  • Sage Therapeutics
    Associate Director, Qa Operations Commercial Lead
    Sage Therapeutics Nov 2023 - Present
    Cambridge, Ma, Us
  • Sage Therapeutics
    Sr Manager, Qa Clinical And Commercial Operations
    Sage Therapeutics Sep 2020 - Nov 2023
    Cambridge, Ma, Us
  • Takeda Oncology
    Principal Gmp Quality Manager/ Clinical Development
    Takeda Oncology Feb 2019 - Sep 2020
    Cambridge, Ma, Us
  • Takeda Oncology
    Gmp Quality Manager/ Clinical Development
    Takeda Oncology Aug 2014 - Jan 2019
    Cambridge, Ma, Us
  • Validant
    Qa Consultant
    Validant Apr 2013 - Jul 2014
    San Francisco, Ca, Us
  • Biogen
    Qa Manager, Corporate Qa (Global Qms/ Document Control)
    Biogen Jul 2008 - Feb 2013
    Cambridge, Ma, Us
  • Alkermes
    Manager, Product Quality Assurance/ Late Phase Clinical Development
    Alkermes Mar 2007 - May 2008
    Dublin, Ie
  • Shire Pharmaceuticals
    Qa Production Support Manager/ Commercial
    Shire Pharmaceuticals Apr 2001 - Apr 2007

Paula Lee, M.S. Education Details

  • Northeastern University
    Northeastern University
    And Medical Devices
  • Sweet Briar College
    Sweet Briar College
    Chemistry/Physics (Minor)

Frequently Asked Questions about Paula Lee, M.S.

What company does Paula Lee, M.S. work for?

Paula Lee, M.S. works for Sage Therapeutics

What is Paula Lee, M.S.'s role at the current company?

Paula Lee, M.S.'s current role is Associate Director, QA Operations Commercial Lead @Sage Therapeutics | GMP System Design and Validation, Packaging Process Validation, Commercial Product Launch, Continuous Improvement, CMC.

What is Paula Lee, M.S.'s email address?

Paula Lee, M.S.'s email address is pa****@****ing.com

What is Paula Lee, M.S.'s direct phone number?

Paula Lee, M.S.'s direct phone number is 141035*****

What schools did Paula Lee, M.S. attend?

Paula Lee, M.S. attended Northeastern University, Sweet Briar College.

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