Shyamosree B.
Program Management & Corporate Governance | Pharma GMP Operations | CMC Quality and Compliance | C-Suite & Board Communications
- Role
- Senior Director, Program Management and Governance at Emergent BioSolutions
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Shyamosree B.
Senior Director with over 15 years of experience in biologics research and development, program and portfolio management, specializing in quality strategy, regulatory compliance, and operational excellence within the biopharmaceutical industry. As the Senior Director of Program Management and Governance at Emergent BioSolutions, I have successfully led global initiatives across biologics and vaccine programs, authored and reviewed key CMC regulatory filings, and managed complex alliances with CDMOs and CROs. I have extensive experience navigating FDA warning letters, conducting Pre-Approval Inspections (PAIs), and overseeing process validations, ensuring compliance and readiness for regulatory reviews. With a strong foundation in cGMP compliance, analytical characterization, and FDA regulatory frameworks, I am skilled in driving transformation and optimizing supply chain operations to ensure excellence and efficiency. My certifications in Agile, Lean Six Sigma Green Belt, and strategic thinking complement my leadership abilities, enabling me to deliver exceptional results and foster high-performance teams.
Experience
Senior Director, Program Management and Governance
May 2023 — Present · Raleigh-Durham-Chapel Hill, NC, US
Key Responsibilities:1. Organisational Transformation and Change Management2. Executive and Board Governance2. Enterprise Risk Management3. Alliance Management with internal and external partnersKey achievements: Quality strategy and operations for organisational transformation across 6 global sites.Led FDA OAI and Warning Letter Remediation Program, delivering successful mitigation and VAI status. Program Lead for regulatory responses, management of legal consultants. Directed program deliverables for 11 enterprise level initiatives.Developed and implemented pilot Quality Maturity assessment at key sites.Lead Enterprise Risk Assessment and development of annual enterprise risk register.
Education
University of Wisconsin-Madison
Doctor of Philosophy (PhD), Chemistry
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