Kelly Richards
- Role
- Executive Director Gra Cmc, Mpd, Sourcing & Due Diligence at Takeda
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Kelly Richards
Dynamic, results driven executive with 23+ years of leadership across Regulatory Affairs,…
Experience
Executive Director Gra Cmc, Mpd, Sourcing & Due Diligence
Feb 2022 — Present
Working across the portfolio (small molecule, biologics, and devices) to drive optimization of internal resources and increased talent through strategic sourcing. Leading future fit goals, building on vision for more effective ways of working and establishing key metrics for GRA CMC & Devices. Implementing model with a focus on strengthening internal strategic abilities for clear risk management, while building cost effective and innovation support for the portfolio.\\\\n• Creating effective model to enable internal strategic focus.\\\\n• Building innovation through considered sourcing (technology, automation) and integrating within internal process.\\\\n• Establishing meaningful metrics, including regular reporting and analysis.\\\\n• Focus on leadership, innovation, business/operational excellence, compliance.\\\\n• Building a scalable regulatory team in global locations.\\\\n• Driving best practice for due diligence and divestment activities.\\\\n• Finding end-to-end solutions.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
Skills
- Project Management
- Manufacturing
- Standard Operating Procedure (Sop)
- Ectd
- Pharmaceutics
- Product Launch
- Cmc
- Change Control
- Analytical Chemistry
- Regulatory Submissions
- Regulatory Requirements
- Gmp
- Corrective and Preventive Action (Capa)
- Good Laboratory Practice (Glp)
- Validation
- Regulatory Affairs
- Pharmaceutical Industry
- Glp
- Sop
- Capa
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