Veerabhadra Nayak
Associate Director Quality Assurance @诺华
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WORK HISTORY
Associate Director Quality Assurance @诺华
DE
As Associate Director Quality Assurance at Novartis in Germany, I led quality oversight across diagnostic, respiratory, IRT, eCOA, imaging, HEOR, translations and BD & L, ensuring compliance with regulatory standards and achieving successful inspection outcomes. Leveraging Six Sigma methodologies (e.g, Fishbone Diagrams, Pareto Analysis, Value Stream Mapping), and systems like TrackWise and Veeva Vault, I established governance frameworks for External Service Providers (ESPs) to address root causes of vendor issues and support R&D transformation initiatives. Using tools such as Microsoft Visio for process mapping and Power BI and Power Query for data analysis, I optimized workflows and monitored key performance metrics. Additionally, I conducted vendor audits, negotiated Quality Agreements, and implemented continuous improvement programs to enhance audit readiness.My responsibilities extended to managing organizational change, where I developed training materials, conducted sessions, and implemented change management strategies to facilitate the adoption of quality and operational initiatives. Applying DMAIC and Kaizen principles, I designed and executed CAPA processes to resolve audit findings, enhance efficiency, and ensure sustainable improvements. Collaborating with senior stakeholders, I provided governance and strategic oversight for R&D projects, effectively driving alignment and mitigating risks.
EDUCATION
Catalyst Clinical Services
Professional Diploma In Clinical Research, Clinical Research
Sangene Biotech Pvt. Ltd
Advanced Diploma, Molecular Biology and Genetic Engineering 2006
European Institute of Management & Technology -EIMT
Doctor of Science, Oncology and Cancer Biology
Sikkim Manipal University
Masters of Bioinformatics 2004, Bioinformatics, and Computational Biology
Sangene Biotech Pvt. Ltd
Advance Diploma, RecombinantDNA Technology, Molecular biology and genetic engineering
Newcastle University
MRes Cancer Research, Molecular Biology, Immunology, Cancer Studies, Protein Structure and Functions, Bioethics, Statistic
Mumbai University
Bachelor, Molecular Biology and Biotechnology; Molecular Biology, Biochemistry; Immunology and Biotechnology
ABOUT VEERABHADRA NAYAK
At Novartis, my role as Associate Director of Quality Assurance centers on leading the quality governance and ensuring adherence to stringent industry regulations. With a solid foundation in ISO 9001 and Six Sigma methodologies, I have established and implemented critical quality assurance standards and procedures across diverse service areas including diagnostics and respiratory. My expertise in quality management is further exemplified through successful collaborations with cross-functional teams to preemptively identify and resolve product quality issues. This has involved conducting meticulous quality audits and championing the development of quality plans aligned with our organizational objectives, thereby reinforcing Novartis\'s commitment to excellence in healthcare.
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