Julianne Davis
Test Engineer at Bungie
- Role
- Contract Generalist Tester at Bungie
- Location
- Ventura, CA, US
- LinkedIn followers
- 500 followers
About Julianne Davis
RESUME: Compliance Program Manager, Anti-Bribery/Anti-CorruptionAmgen June 2019-September 2021Senior Associate, Device Regulatory AffairsAmgen July 2015-June 2019• Process Creator/Owner/Manager for:o Led and own the MAC/Determinations Collaboration Process. Improvements led to 63% increase in potential devices from Commercial for more visibility, and 133% decrease in determination turnaround time (30 to 10 days).• Wrote, uploaded and obtained approval for over 50 Medical Device Determinations in EDM Quality, analyzing and applying current FDA CFR, guidances, databases and standards. • Device Regulatory Lead on Imlygic and ABP 938 Biosimilar.Account Supervisor, MAC - Amgen Full Potential Project (Aisle 9)Amgen April 2014-July 2015• Recruited, managed and provided leadership to 11 direct reports in Material Approval and Compliance (MAC) Group. Central touch-point for ensuring jobs across Amgen’s product porfolio were created efficiently and at/above SLA-set 95% accuracy level. • Managed end-to-end MAC process with over 200 Marketing and other sponsors’ promotional materials by adhering to process via File Standards, Grid and MAC SOP.Account Supervisor, MAC Reg Release Process (Spectrum)Amgen August 2009-April 2014• Supervisor and leader for team of 3 that performed final step in ensuring Regulatory compliance and release of all FDA promotional MAC materials. Submissions sent within 99% quality level. Consultant, UCLA Master’s ThesisUCLA GLOBAL ACCESS PROGRAM June 2011-December 2011• Master’s Thesis: Consultant on five-person UCLA group for New Zealand-based 3D graphics company to help them achieve greater market share. Compiled over 65 hours of primary research for business recommendation.
Experience
Contract Generalist Tester
May 2022 — Present
S18S19Delta Team - Lightfall plus more
Education
UC Santa Barbara
Bachelor of Arts (B.A.), Political Science and Government
1998 — 2002
UCLA Anderson School of Management
MBA, Business
2009 — 2012
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