Jake Brown
Director, Vendor Quality Oversight at Alnylam Pharmaceuticals
- Role
- Director, Vendor Quality Oversight at Alnylam Pharmaceuticals
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Jake Brown
Quality Assurance professional that provides change management and quality system support to medical device and biopharmaceutical organizations. My focus is facilitating remediation activities to close quality-threatening gaps. I have experience in quality management systems and compliance, clinical research and development, regulatory strategy, and business operations. My goal is harmonize and improve quality management systems for organizations experiencing significant growth or internal and/or external change.
Experience
Director, Vendor Quality Oversight
Apr 2024 — Present · Cambridge, MA, US
Responsible for the quality oversight of all GCP/GLP outsourced services and to ensure the appropriate escalation of emerging risks and concerns. A key function of this role is to interface with the Alnylam Development organization and with key partners to ensure quality and compliance across clinical trials.
Education
Worcester Polytechnic Institute
Bachelor of Science (BS), Biology and Biotechnology
2011 — 2015
Skills
- Project Management
- Good Clinical Practice (Gcp)
- Business Development
- Business Planning
- Microsoft Office
- Clinical Trials
- Interpersonal Skills
- Service Delivery
- Communication
- 21 Cfr Part 11
- Iso 13485
- Interpersonal Communication
- Google Docs
- Community Service
- U.s. Title 21 Cfr Part 11 Regulation
- New Business Development
- Team Leadership
- Iso 9001
- Cell Culture
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