
Kyle Mikulis
Experienced Quality Assurance professional in the biotech/pharmaceutical industry managing staff and driving continuous improvement with an emphasis in... | Cambridge, Massachusetts, United States
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Kyle Mikulis’s Emails ky****@bi****.com
Kyle Mikulis’s Phone Numbers No phone number available.
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Kyle Mikulis’s Location Cambridge, Massachusetts, United States
Kyle Mikulis’s Expertise Experienced Quality Assurance professional in the biotech/pharmaceutical industry managing staff and driving continuous improvement with an emphasis in clinical and commercial product complaint business processes. Experienced and knowledgeable in diverse products ranging from small molecules, biologics, combination products, and medical devices. Incorporates strong communication skills and cross-functional relationship building to enhance compliance and process-based improvements for a company’s products. Leadership: Developed Biogen’s overall complaint philosophy and vision establishing an 80/20 risk-based approach utilizing real-time trending with significant Quality Assurance oversight. Encouraged and led continuous improvement initiatives to further drive process efficiencies. Management: Experienced in managing staff, mentoring new hires, and educating overall team in the development of critical investigation skills, while maintaining departmental budget targets. Communication: Experienced in cross-functional partnerships with other teams (Quality, Logistics, Pharmacovigilence, Manufacturing, Commercial, Supply Chain, Technical Development, CMOs, and Vendors) to implement quality improvements in both clinical and commercial products. Routinely presented to Senior Quality leaders in Management Review and Post-market Surveillance forums. Analytical: Identified and developed critical metrics and analytics using MS Excel and TrackWise used for business decisions by Senior Quality Management across both operational and product-based performance parameters.
Kyle Mikulis’s Current Industry Alnylam Pharmaceuticals
Kyle
Mikulis’s Prior Industry
Meditech
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Biogen
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Aegerion Pharmaceuticals
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Alnylam Pharmaceuticals
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Work Experience

Alnylam Pharmaceuticals
Associate Director, GCP QA
Sat Jan 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Alnylam Pharmaceuticals
Senior Manager, GCP QA
Thu Nov 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Aegerion Pharmaceuticals
Senior Product Quality Manager, QA
Tue Mar 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Oct 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Biogen
Manager, Quality Assurance Technical Product Complaints
Sun Jan 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Biogen
Senior Specialist II, Technical Product Complaints
Sat Jan 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Biogen
Specialist, MS ActiveSource
Wed Jan 01 1997 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time)
Meditech
Consultant, Lab Module Applications
Mon Jan 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Sep 01 1997 00:00:00 GMT+0000 (Coordinated Universal Time)