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Manager, Clinical QA Program Lead
Johnson & JohnsonManager, Clinical QA Program Lead at Johnson & Johnson ensuring compliance and audit quality in global therapeutic programs. Overseeing audit strategies, conducting inspections, and collaborating across teams.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and executing audit strategies within GxP-regulated environments, with a strong focus on GCP audits and compliance. Capable of leading audit programs, preparing comprehensive reports, and fostering collaboration among stakeholders.
Highest-signal resume keywords
GCP AuditsAudit Strategy DevelopmentCompliance Audit ManagementStakeholder CollaborationOperational Audit Planning
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
GCP AuditGxP AuditAudit StrategyCompliance MonitoringAudit ReportingAudit PlanningRisk AssessmentRegulatory ComplianceData AnalysisQuality Assurance
Soft Skills
LeadershipCommunicationCollaborationProblem-SolvingCritical Thinking
Industry Keywords
Clinical AuditTherapeutic ProgramsCompliance FieldR&DAudit Schedule
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Audit strategy: Drives and delivers audit strategies and capabilities for applicable therapeutic program level(s), Clinical System, Clinical Supplier, or Local Operating Company audits.
- Fosters the partnership between audit strategy and execution teams and enhance the value of Clinical audit programs.
- Monitors audit outcome trends and identifies collaboration opportunities with stakeholders to resolve compliance related matters.
- Conducts GCP audits & supports GxP Audits as applicable (expected up to 50% time).
- Develops tactical and operational audit plans to implement and deliver domain-specific audit strategies.
- Independently leads and manages domain-specific compliance audit programs as laid down in a comprehensive audit schedule.
- Guides auditors in the scope definition, planning, conduct and reporting of audits.
- Prepares and reviews audit summary reports to share/escalate significant information with senior leaders.
Requirements
What you’ll need- A minimum of a bachelor’s or equivalent University degree is required.
- Requires at least 5 years’ experience in an applicable compliance field and/or equivalent time and experience in a related R&D area (GxP-regulated discipline).
- Experienced in conducting GCP audits.
- Experienced in developing audit strategies and capabilities for applicable therapeutic program level(s), GCP System, and/or GCP Supplier audits.
- Must be able to work onsite 3 days/week at JNJ location.
Benefits
Comp & perks- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development