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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in GCP compliance, quality risk management, and regulatory requirements, with a strong focus on clinical trial processes and stakeholder collaboration. Proven ability to conduct risk assessments, manage CAPA processes, and support audits and inspections in regulated environments.
Highest-signal resume keywords
GCP ComplianceQuality Risk ManagementRegulatory ComplianceClinical Trial ProcessCAPA Management
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 ComplianceQuality AssuranceRegulatory RequirementsRisk AssessmentDeviation ReportingRoot Cause AnalysisCAPA DevelopmentAudit SupportInspection ReadinessVendor Oversight
Soft Skills
Strong CommunicationOrganizational SkillsProblem-SolvingCollaborationAttention to Detail
Industry Keywords
Pharmaceutical IndustryBiotechnologyAcademic ResearchICH GuidelinesGLP RequirementsCRO GovernanceClinical Quality ManagementRegulatory InspectionsCompliance MetricsStakeholder Partnership
About the role
Key responsibilities & impact- Provide quality leadership and guidance to R&D stakeholders on GCP-related activities
- Serve as a subject matter expert for clinical compliance matters
- Act as a Clinical Compliance representative on clinical study teams across assigned therapeutic areas
- Build collaborative partnerships with cross-functional stakeholders and provide ongoing coaching and compliance guidance
- Conduct risk assessments of clinical trial activities and identify priority studies, key compliance activities, compliance metrics, and high-risk vendors
- Identify, assess, and escalate significant quality and compliance issues, including support for serious breach evaluations
- Participate in CRO and vendor governance activities for assigned studies and therapeutic areas
- Maintain working relationships with CRO quality teams to review and address quality and compliance matters
- Support vendor evaluations as a subject matter expert
- Develop responses and CAPAs associated with internal and external audit findings
- Provide guidance on deviation reporting, root cause analysis, and CAPA development and evaluation
- Identify trends in quality and compliance risks and implement effective, risk-based solutions
- Support internal audits, regulatory inspections, inspection readiness activities, and project team training
Requirements
What you’ll need- Bachelor's degree required (life science or a related discipline preferred)
- Minimum 5 years of experience within the academic, pharmaceutical, or biotechnology industry
- 3+ years in a clinical compliance, quality assurance, or regulatory compliance role
- Thorough knowledge of drug development and the clinical trial process
- In-depth knowledge of current regulatory requirements and ICH GCP guidelines
- Experience with international regulations, guidelines, and standards
- Strong written and verbal communication, organizational, and problem-solving skills
- Ability to work independently, manage multiple priorities, and collaborate effectively within a team environment
- Strong expertise in GCP compliance, quality risk management, and stakeholder partnership
- Experience working within pharmaceutical, biotechnology, academic, or other regulated clinical research environments
- Ability to influence, coach, and collaborate effectively across cross-functional teams
- Exceptional attention to detail and commitment to regulatory compliance
- Experience supporting audits, inspections, CAPA processes, and clinical quality management activities
- Working knowledge of CAPA management, risk management, regulatory inspections, and GLP requirements
- Experience supporting vendor oversight and governance activities
- Experience leading or supporting inspection readiness initiatives and regulatory inspection preparation
Benefits
Comp & perks- Permanent position
- Flexible work arrangements
- Growth opportunities
- Opportunity to build broad organizational partnerships
- Opportunity to strengthen leadership capabilities
- Opportunity to expand expertise across quality, compliance, and clinical development