PDA Southern California Chapter

Chapter Officers

• 
  Amy Stanton

  Quality Compliance Senior Manager, External Affairs Operations Quality

  President

  Amgen, Inc.

  pdasoutherncaliforniachapter@pda.org

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  Amy Stanton joined Amgen in 2003 in Thousand Oaks, CA. During her time at Amgen, she has held multiple positions within the Amgen Corporate Quality Compliance Department and External Affairs. Amy helped develop and support the GxP Intelligence Program and the Amgen Compliance Intelligence Program at Amgen and continues to enhance and manage the program over the years.

  Currently As Chair of Amgen’s RIVER (Recognition of Indigenous People, Values & Environmental Resources), she looks to connect the business to the current and historical importance of Indigenous Peoples.

  Amy co-founded the Regulatory Intelligence Discussion Group (RIDG), establishing a group of industry representatives to share and benchmark intelligence information and requirements. Currently Amy is Rapporteur Supporter/Content Manager for the ICH Q3E Guideline on Extractables and Leachables.  Previously she was Project Manager for PDA Technical Reports for Reprocessing of Biopharmaceuticals (TR No. 74) and Visible Particulates (TR No. 85)

  Amy volunteers and sits on the Board for Honoring Our Fallen, a non-profit organization dedicated to serving our nation’s fallen and the families these heroes have left behind

  Amy is proud tribal member of the Choctaw Nation of Oklahoma and is proud to share with friends, family and those who want to learn more about the traditions and culture so that it continues to live through her, her daughter and future generations to come.

  Amy currently sits on the Board for PDA Southern California as President.

• 
  Abel Cortez

  Compliance and CQV Regional Manager

  President-Elect

  Integrated Project Services

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  Abel C. Cortez is the Compliance and CQV Regional Manager for Southern California at Integrated Project Services (IPS), which he joined in 2022. He brings over 25 years of experience in Quality Compliance, Commissioning, Qualification, and Validation (CQV), and Project Delivery across the biopharmaceutical and medical device industries.

  A seasoned leader within professional societies, Abel previously served on the leadership board of the ASQ Orange Empire Section. At IPS, he continues his commitment to service as the Chair of the Veterans Network Employee Resource Group (ERG). Within his local community, he also serves as a robotics coach at his daughter’s school.

  Abel holds a B.S. in Chemical Engineering from the University of San Marcos in Lima, Peru, and an MBA from DeVry University. He is a certified Project Management Professional (PMP), Certified Quality Engineer (CQE), and Certified Quality Auditor (CQA). In addition to his leadership in PDA, he maintains active memberships with ISPE and ASQ.

  Originally from Lima, Peru, Abel has been a resident of Los Angeles since 1999. He currently resides in the South Bay with his wife, younger son, and daughter.

• 
  Marsha Steed

  Founder and President

  Secretary

  Steed MicroBio, LLC

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  Marsha Steed has over 30 years of experience as a microbiologist working in the pharmaceutical, biotechnology, and medical device fields. Marsha is the Founder and President of Steed MicroBio, LLC, an independent microbiology consulting firm, and a Senior Microbiology Associate/Sterility Assurance Expert at Jeff Yuen & Associates, Inc., a consulting firm. Marsha is a globally recognized consultant specializing in sterility assurance and contamination control matters in pharmaceutical, biotech, and medical device companies.

  Marsha served as a USP Microbiology Expert Committee member (2020–2025 cycle) and as Chair of the USP Microbial Control and Sterility Assurance Subcommittee. Marsha studied Biology at Western New England University in Springfield, MA.

  Marsha is active in the industry and currently serves on the Parenteral Drug Association (PDA) ATMP Advisory Board. She has previously served on the PDA Education Advisory Board (EAB) and Scientific Advisory Board (SAB), and has participated in numerous PDA Task Forces and meeting planning committees. She has also served as Chair of the PDA Annual Meeting and PDA Microbiology Meeting. Marsha is a former Notified Body ISO inspector.

• 
  Jason Kerr

  GXP Senior Specialist

  Treasurer

  Moderna

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  Jason Kerr is an experienced quality and regulatory intelligence professional and has been a champion in engaging, connecting, and promoting regulatory compliance in the dynamic biopharmaceutical landscape. As a leader at Moderna, Jason strives to ensure regulatory compliance by monitoring the regulatory landscape and engaging with external stakeholders on emerging topics.

  Jason holds a Bachelor of Science (BS) in Biochemistry from UCLA, a Master of Business and Science (MBS) from the Keck Graduate Institute, a Master of Business Administration (MBA) from the Quantic School of Business and Technology, and a certificate in Bioscience Industry Law and Practice from Southwestern Law School.