Susan Greenbaum
Principal Clinical Controls Manager @ Stryker | Clinical Compliance
- Role
- Principal Clinical Controls Manager at Stryker
- Location
- Las Vegas, NV, US
- LinkedIn followers
- 500 followers
About Susan Greenbaum
With nearly two decades in clinical research and quality assurance, my career is marked…
Experience
Principal Clinical Controls Manager
Mar 2019 — Present
Liaise and interface with internal and external stakeholders in order to assess and support compliance with FDA Regulations, ISO Standards, international guidelines (e.g. ICH-GCP) and applicable regulations, as well as development and maintenance of clinical processes at Stryker Neurovascular.Establish a purpose for clinical within the quality management system and deliver sustainable quality solutions for data integrity and patient safety.Provide strategic leadership for the oversight of clinical compliance activities including but not limited to regulatory inspections, internal and external audits.
Education
Florida International University
B.A., Environmental Studies
1996 — 1998
Skills
- Design Control
- Validation
- Change Control
- Certified Iso 9000:2000 Lead Auditor
- Clinical Development
- Quality Control
- Gmp
- Life Sciences
- Quality Assurance
- R
- Biotechnology
- Ce Marking
- Glp
- Technology Transfer
- Quality System
- V&V
- Regulatory Affairs
- Lifesciences
- Cardiology
- Ide Regulations
- Quality Auditing
- Clinical Trials
- 21 Cfr Part 11
- Iso
- Pharmaceutical Industry
- Fda
- Iso 13485
- Ivd
- Ceritifed Iso 13485:2003 Auditor
- Regulatory Submissions
- Ctms
- Medical Devices
- Clinical Research
- Capa
- Gcp
- Biopharmaceuticals
- Regulatory Requirements
- Commercialization
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