About Anastasiia
Senior Operations Leader with 10+ years of experience in global pharma & life sciences. Specialized in operational excellence, process optimization, cross‑functional alignment, quality compliance (GxP, QMS, SOP), audit preparation and large‑scale organizational transformation across Europe. Deep expertise in EU regulatory landscape, efficiency improvement, and cross‑regional stakeholder management.
English
Native or bilingual
Russian
Native or bilingual
Remote only
Primarily works remotely
Experience
- Novartis Farmaceutica S.A.,Region Europe Operations Hubs LeadJanuary 2024 - Today (2 years and 5 months)Barcelona, Spain• • Build & lead high‑performing QA/operations hub; objective setting, capacity & capability planning• • Ensure timely market release compliant with cGMP/MAH; oversee deviations/complaints and market actions• • Own customer/stakeholder satisfaction loop; run OpEx initiatives and hub centralization roadmap
- Novartis GlobalOne Button Batch Release Change & Communication Manager / S4 HANA Solution Design ManagerJanuary 2022 - January 2024 (2 years)• • Global program management; change impacts; global procedures & training; validation with IT• • Onboarding support for entities; configuration mgmt; SteerCo reporting; risk/issue logs
- Novartis Neva (RU)Qualified Person; QA Operations SpecialistDecember 2021 - January 2024 (2 years and 1 month)• • Batch certification; dossier compliance; audit/inspection readiness; complaints & investigations• • Change control, deviation mgmt, validation/qualification support; APQR; risk assessments
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Education
- Qualified Person advanced trainingSechenov UniversityQualified Person advanced training
- Biotechnology EngineerState Chemical Pharmaceutical AcademyBiotechnology Engineer