
Larisa Primak
With over 20 years of experience in the Life Science industry, I am a US Lead, IT Quality... | Newton Upper Falls, Massachusetts, United States
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Larisa Primak’s Emails lp****@ar****.com
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Larisa Primak’s Location Newton Upper Falls, Massachusetts, United States
Larisa Primak’s Expertise With over 20 years of experience in the Life Science industry, I am a US Lead, IT Quality at argenx, a global biotechnology company that develops and commercializes innovative therapies for patients with severe autoimmune diseases and cancer. I am certified in Women's Leadership Program: Leading With Power and Influence from Yale School of Management, a prestigious program that equips women leaders with the skills and strategies to advance their careers and organizations. My core competencies include Data Integrity, Risk Based CSV / CSA, and QMS, and I have extensive knowledge of GxP, SOX, and GDPR regulations. I have successfully led and supervised the validation and administration of various GxP systems such as Veeva Quality Vault, Tracelink, Azure Data Lake and Trackwise Digital, ensuring the quality, integrity, and compliance of the computerized systems across Clinical, Manufacturing, and Commercial / PV business functions across the Life Science industry. I am passionate about IT Processes continuous improvement and I have implemented or revised several SOPs to streamline the validation and periodic review processes. I have excellent efficiency, programmatic approach, priority management, and communication skills. I thrive in collaborating with diverse stakeholders and teams across IT and Quality. My mission is to leverage my IT Quality and Compliance expertise to deliver the highest standards of quality and compliance for the benefit of the patients and the company.
Larisa Primak’s Current Industry Argenx
Larisa
Primak’s Prior Industry
Speedline Technologies
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Genzyme
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Sanofi Genzyme
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Bristol Myers Squibb
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Biogen
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Insulet
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Epizyme
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Argenx
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Work Experience

Argenx
US Lead, Business Information Systems (BIS) Quality
Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Epizyme
Manager, Quality Assurance, CSV & QMS
Thu Apr 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Insulet
Sr. SW Validation Quality Engineer
Tue Jan 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Mar 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Biogen
IT Validation Analyst
Thu Feb 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Bristol Myers Squibb
IT Automantion Validation Consultant
Thu Jun 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Feb 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Sanofi Genzyme
IT Compliance and Validation Lead
Thu Sep 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jul 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Genzyme
Oracle E-business Suite (EBS) Change and Release Manager
Wed Jul 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Sep 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Genzyme
Technical Project Lead / DBA
Mon May 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jul 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time)
Speedline Technologies
Senior Programmer/Analyst
Sun Mar 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Apr 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time)