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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Assurance and auditing within GxP environments, with a strong focus on compliance with regulatory requirements such as EU GVP and USFDA CFRs. Proven ability to develop and manage audit programs and risk assessment methodologies while fostering a culture of quality across the organization.
Highest-signal resume keywords
GCP Auditing ExperienceGVP Regulatory ComplianceAudit Program ManagementQuality Risk Assessment MethodologyExcellent Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
AuditingQuality AssuranceRisk-Based Audit PlansCompliance MonitoringQuality Risk ManagementAudit DocumentationGxP ExpertiseVendor OversightStrategic Audit ProgramsInternal Audits
Soft Skills
Attention to DetailOrganizational SkillsProactive ApproachFacilitation Skills
Industry Keywords
EU GVPUSFDA CFRsJMPAICH-E6Biomedical SciencesNatural SciencesHealth SciencesQuality as a ServiceAudit UniverseVendor Management
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Foster a culture of quality within the Company organization and act as an ambassador for the QA department
- Prepare, maintain, and execute internal and vendor Strategic and Annual Audit Programs
- Lead the design, implementation, and management of internal and vendor audits
- Lead corresponding quality risk management activities
- Develop and maintain the internal Quality Risk Assessment methodology
- Develop and maintain a comprehensive Audit Universe
- Lead Quality Assurance activities related to procurement and vendor oversight
- Develop, maintain, and manage mechanisms for ongoing monitoring and compliance with applicable laws and regulations, including EU GVP, USFDA CFRs, JMPA, and ICH-E6
- Partner with Vendor Management and operations teams to drive risk-based and compliant audit strategy
- Coordinate and contribute to internal system and vendor audits according to the Company Audit Plan
- Manage pre-audit and post-audit activities
- Conduct audits or coordinate audit documentation peer review and quality control activities within GxP expertise
- Plan, coordinate, or conduct audits and provide GxP QA consultancy for client-contracted Quality as a Service activities
- Monitor organizational compliance and assess its impact on audit strategy, plans, and execution
Requirements
What you’ll need- Bachelor’s or Master’s degree in biomedical sciences, natural sciences, health sciences, or another relevant scientific discipline, or an equivalent combination of advanced education and relevant industry experience
- Experience with both GVP and GCP regulatory requirements, or willingness to broaden expertise
- At least 3 years of direct auditing experience in GCP and/or GVP area
- At least 2 years of experience in audit program management, including development and maintenance of risk-based audit plans
- Organization skills and attention to detail
- Excellent communication and facilitation skills within a global organization
- Proactive approach
- Fluent in English
Benefits
Comp & perks- Remote work option
- Work-life balance
- Collaborative, international team environment
- Career growth opportunities
- Trusted ownership and autonomy
- Passionate and collaborative team of clinical research, pharmacovigilance, and quality consulting experts