Vanya has over 20 years of experience in pharmaceutical and medical device quality and regulatory affairs, serving 20-30 companies each year on a variety of topics, including cross-company benchmarking of quality costs and performance, quality and regulatory organizational models, quality systems and quality culture, optimizing and automating quality and regulatory processes. She has worked with associations such as ISPE and MDIC on industry initiatives related to quality metrics and cost of quality.
Vanya founded and leads most of our proprietary quality and regulatory benchmarking solutions since 2006, including:
- POBOS/MDB quality benchmarking of performance, total cost of quality, processes, and culture at the plant and corporate level (currently includes more than 55 pharma companies and 20 medical device companies)
- MedTech Regulatory Affairs benchmark (18 companies) of operating models, technology enablement, resourcing, and footprints
- ACQUA capabilities benchmark (16 companies) of the current state of quality capabilities across subfunctions, locations, and businesses
- Custom benchmarks of quality organizational archetypes, QMS maturity, and quality culture maturity
Other examples of Vanya’s client work include:
- leading QMS design and QA processes optimization efforts at multiple life sciences companies—from overall archetypes and business cases through process design, implementation roadmaps, and playbooks. Examples of reimagined processes include integrated risk management, deviations and CAPA, change controls, GMP training, CMO oversight and batch release, and supplier qualification
- streamlining and digitizing complaints processes at two medtech companies, including revising event coding to align with risk factors, developing automated intake portals and code look-up tools, and segmenting investigation approaches into risk-based tiers
- performing quality performance and compliance diagnostics at several pharma and medtech companies (including organizational design and headcount deployment, site and above-site productivity, risk assessment, and benchmarking)
