Global Third Party & Audit Manager
Мэтч & Сопровод
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Описание вакансии
TL;DR
Global Third Party & Audit Manager (GxP): Own and lead global compliance monitoring programs and risk-based audit schedules for third-party suppliers across GMP, GDP, GCP, GLP, GVP domains with an accent on qualification, oversight, and regulatory alignment to EU, UK, FDA standards. Focus on managing CAPAs, vendor performance KPIs, internal audits, and cross-functional collaboration for compliant clinical trial supply and operations.
Location: Remote from UK or EU
Company
partners with sponsors for early access programs, clinical trial services, supply chain, and market access, distributing to over 120 countries worldwide.
What you will do
- Own global GxP third-party compliance monitoring, including qualification, requalification, and risk-based disqualification.
- Design and manage global audit programs for GMP, GDP, GCP, GLP, GVP, both remote and on-site.
- Oversee third-party audits, risk-assess findings, track CAPAs, and monitor performance via KPIs, deviations, and metrics.
- Maintain approved supplier lists with criticality ratings and ensure alignment with EU, UK, FDA regulations and SOPs.
- Lead internal audits, support Quality/Technical Agreements, new vendor onboarding, and regulatory inspection readiness.
- Escalate risks, drive remediation, and collaborate with Procurement, Supply Chain, Clinical Ops, Regulatory, and others.
Requirements
- Bachelor’s or Master’s in Life Sciences, Pharmacy, Chemistry, or related
- Extensive GMP, GDP, GCP knowledge; formal lead auditor certification (e.g., IRCA/CQI, ISO 9001)
- 6–7+ years in Quality Assurance, preferably vendor/audit management
- Strong risk-based thinking, analytical skills, communication, and proficiency in MS Office
- Experience with clinical trial supply preferred
Nice to have
- Experience with GLP, GVP, unlicensed supply
Culture & Benefits
- Private healthcare insurance, long-term illness cover, death in service
- Salary sacrifice pension, annual leave, paid maternity/paternity leave, volunteer day
- Wellness initiatives, growth opportunities, team events
- DEI commitment, equal opportunity employer, smoke/drug/alcohol-free environment
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