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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in GCP and GLP quality assurance, with a strong focus on compliance, audit management, and regulatory guidelines. Proven ability to lead cross-functional teams and develop effective quality management systems in clinical and non-clinical environments.
Highest-signal resume keywords
GCP Quality AssuranceGLP Quality AssuranceClinical Quality AssuranceRegulatory Authority InspectionsQuality Management Systems
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial Documentation ReviewAudit Preparation and ExecutionCAPA Plan DevelopmentCompliance Issue ResolutionGxP-Compliant ProceduresICH Guidelines KnowledgeFDA Regulations UnderstandingEU Requirements KnowledgeDeficiency Impact AssessmentStudy-Specific Audit Plans
Soft Skills
Excellent Interpersonal SkillsPersonal IntegrityProfessional MannersRelationship Building
Industry Keywords
Clinical Quality AssuranceNon-Clinical Quality AssuranceGlobal Clinical Trial ConductRegulatory ComplianceInspection Readiness
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide leadership on GCP and GLP quality assurance support and guidance to clinical and non-clinical stakeholders
- Act as the primary Quality business partner to R&D functional leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance areas
- Partner with teams to resolve compliance issues at vendors and investigator sites
- Assess the impact of deficiencies and recommend corrective actions
- Assist in developing and implementing CAPA plans and investigations in response to quality issues, audits, and inspections
- Review clinical trial documentation and regulatory submission materials for completeness and compliance
- Develop and maintain study-specific audit plans
- Support audit preparation, site selection, execution, and response coordination
- Contribute to implementation and continuous improvement of GxP-compliant procedures and operations
- Support inspection readiness activities and provide guidance during GxP inspections
- Perform related duties and special projects as assigned
Requirements
What you’ll need- BS/BA Degree in a scientific discipline
- Advanced degree preferred
- 12+ years of progressive experience in a related industry
- 8+ years’ experience in a Clinical Quality Assurance role, including experience with external and internal audits
- Experience in a Non-Clinical Quality Assurance role is a strong plus
- Demonstrated experience working with clinical trial teams
- Extensive experience with global clinical trial conduct
- Knowledge and understanding of applicable ICH Guidelines, FDA Regulations and EU Requirements
- Previous experience supporting Regulatory Authority Inspections preferred
- Previous experience in development and oversight of Quality Management Systems
- Excellent interpersonal skills, personal integrity, professional manners and ability to gain respect and develop good working relationships with cross-functional personnel at all levels
- May require up to 10% domestic and international travel
- Must be authorized to work in the U.S.
Benefits
Comp & perks- Comprehensive benefits and work-life resources
- Physical and emotional wellness support
- Financial wellness support
- Support for caregivers
- Competitive compensation and benefit package