Ashley Snipes
Associate Director, GCP Compliance
- Role
- Associate Director, Gcp Compliance at Takeda
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Ashley Snipes
Experienced Quality Assurance professional with a demonstrated history of working in the pharmaceutical industry.
Experience
Associate Director, Gcp Compliance
Feb 2025 — Present
Compliance Management• Create compliance strategy for Inspection Management. • Partner with R&D Quality to define the logistics, roles, responsibilities, and tools related to inspection management• Facilitate clinical trial delivery internal audits with study teams and functional areas including but not limited to: study team preparation, facilitating audit requests, managing audit responses and CAPA development and implementation. Partner with Quality Assurance to ensure appropriate audit scopes and clinical trial delivery participation.• Lead clinical trial functional areas and study teams on issues related to GCP compliance and liaise with study execution teams on compliance to clinical trial delivery procedures and developing effective mitigation and escalation strategiesCompliance Assessments• Proactively identify process/therapeutic area/project risks and develop/lead assessments to assess compliance• Advise process owners and functional areas on the development and implementation of effective mitigation and escalation strategies for projects to address risks and issues• Develop, lead and oversee compliance assessments to address GCP Quality Plan, CAPAs/ECs and liaise with QA to ensure adherence to the plan GCP Compliance Metrics and Reporting• Engage and build relationships with clinical trial delivery functions, R&D QA, and other stakeholders on performance metrics, analytics and reporting for GCP compliance activities• Identify, develop, and track KPIs, metrics and dashboards to track process quality and compliance
Education
Campbell University
Bachelor's degree - Pharmaceutical Sciences, Pharmaceutical Sciences
2000 — 2004
Campbell University
Bachelor of Science, Pharmaceutical Sciences
2000 — 2004
Skills
- Pharmaceutical Industry
- Sop
- Gmp
- Glp
- Hplc
- Cgmp
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.