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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Clinical Quality Management, including Quality Management Systems (QMS), Good Clinical Practice (GCP), and regulatory compliance. Proven ability to lead cross-functional teams, manage inspections, and implement effective CAPA processes while leveraging data analytics and AI-driven approaches.
Highest-signal resume keywords
Clinical Quality ManagementQuality Management Systems (QMS)Regulatory ComplianceCAPA ManagementData Analysis
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Root Cause IdentificationRisk ManagementProject ManagementProcess ImprovementsIndependent Root Cause Analysis (RCA)
Soft Skills
Superior Oral and Written Communication SkillsAbility to Lead Cross-Functional TeamsStrategic ThinkingTaking InitiativeOrganizational Skills
Tools & Technologies
AI-Driven ApproachesData Analytics
Industry Keywords
Clinical TrialsRegulatory InspectionsICH GCP GuidelinesPharmaceutical IndustryQuality Oversight
About the role
Key responsibilities & impact- Execute clinical quality oversight activities within assigned clinical trials
- Provide proactive quality management, risk-based quality oversight, and clinical trial inspection management
- Support Trial Teams in embedding quality into sponsored trials and conducting quality reviews
- Ensure robust service provider oversight and manage critical quality issues
- Act as a Process Subject Matter Expert on quality processes, standards, and regulatory requirements
- Identify, investigate, escalate, and resolve study-level quality issues, including Significant Quality Issues and Serious Breaches
- Lead Inspection Hypercare Teams to maintain ongoing inspection readiness
- Provide operational oversight for sponsor inspections and act as Control Room Lead or Support
- Act as Inspection Lead for site inspections and conduct pre-inspection visits
- Author inspection communications, including daily summaries, outcomes, and issue escalations
- Coordinate inspection responses, root cause analysis, CAPA, regulatory commitments, and documentation
- Support Quality Assurance audits before, during, and after audits
- Collaborate with the Clinical Quality Risk Manager to operationalize quality risk management
- Serve as primary clinical quality point of contact for assigned key service providers
- Develop and manage service provider clinical quality agreements
- Support quality-related mergers and acquisitions activities
- Contribute to CQO infrastructure, process innovation, and special projects
- Apply AI-driven approaches and data analytics to improve efficiency and decision-making
Requirements
What you’ll need- Bachelor’s or Master’s Degree or equivalent in a health care or scientific area
- Minimum of 8 years of relevant experience in the pharmaceutical industry and/or clinical research
- Robust knowledge of quality management and clinical trial operations
- Comprehensive knowledge of Quality Management Systems (QMS), ICH GCP guidelines, and worldwide Regulatory Health Authority requirements
- Advanced experience in independent root cause analysis (RCA), CAPA development and effectiveness management, and service provider quality oversight
- Superior oral and written communication skills in an international, matrixed environment
- Excellent project management and organizational skills
- Ability to lead cross-functional teams of business and clinical professionals
- Ability to act urgently and decisively on worldwide health authority inspection matters
- Ability to analyze, interpret, and solve complex quality and compliance issues
- Ability to think strategically and objectively with digital savvy, including awareness of AI and machine learning tools
- CAPA Management
- Clinical Quality Management
- Data Analysis
- Good Clinical Practice (GCP)
- Process Improvements
- Project Management
- Regulatory Compliance
- Regulatory Inspections
- Risk Management
- Root Cause Identification
- Strategic Thinking
- Taking Initiative
- US and Puerto Rico residency eligibility
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Remote work arrangement
- 25% travel allowance/requirement