Scott Detmer
Executive Director, Head of Clinical QA at Allogene Therapeutics
- Role
- Executive Director, R & d Quality at Allogene Therapeutics
- Location
- Thousand Oaks, CA, US
- LinkedIn followers
- 500 followers
Experience
Executive Director, R & d Quality
Nov 2024 — Present · Thousand Oaks, CA, US
Provide Quality oversight for development, clinical trial and pharmacovigilance activities. Assess activities conducted internally and outsourced to CROs/vendors to ensure practices are compliant with relevant cGxP (GLP, GCLP, GCP, GVP) requirements and expectations.Partner with R&D stakeholders to establish and maintain the GxP Quality Management System. Conduct gap assessments and establish quality plans to drive continuous improvement.Support selection, management, and inspection readiness of CROs/vendors by performing audits, gap assessments and quality system/operational reviews.Interact with Quality Units of CROs/vendors to ensure Sponsor quality interests are met and that high performing relationships are maintained. Contribute to establishment of relevant CRO metrics.Develop and execute R&D/Clinical Audit Plan. Integrate activities into the Allogene GxP annual audit schedule and processes. Execute audits and provide oversight of 3rd party auditors.Support clinical study teams during generation and closure of deviations, investigations and CAPAsWork with cross-functional colleagues to establish relevant Management Review metrics and Quality Review forums to manage/escalate quality issues and foster a culture of continuous improvement.Lead R&D inspection readiness and execution activities. Host GLP, GCLP, GCP, GVP inspections. Lead the development of responses and remediation of gaps. Represent Sponsor to support regulatory inspections and responses at CROs/vendors and clinical investigator sites.
Education
Colorado State University
MBA
2001 — 2004
UCSB
Bachelor of Science
1993 — 1996
Skills
- Gcp
- Glp
- 21 Cfr Part 11
- Gmp
- Computer System Validation
- Project Management
- Sop
- Fda
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