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Manager, Clinical QA Program Lead
Johnson & JohnsonManager, Clinical QA Program Lead role at Johnson & Johnson focusing on audit strategies and delivering compliance for therapeutic programs.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in conducting GCP audits and developing audit strategies for therapeutic programs, with a strong focus on compliance within GxP-regulated disciplines. Proven ability to lead and manage domain-specific compliance audit programs effectively.
Highest-signal resume keywords
GCP Audit ExperienceGxP Compliance ExpertiseAudit Strategy DevelopmentOperational Audit PlanningClinical QA 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
GCP AuditsGxP AuditsAudit Strategy DevelopmentCompliance AuditingOperational Planning
Industry Keywords
Therapeutic ProgramsClinical QAR&D ComplianceDomain-Specific AuditsCompliance Field Experience
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Drive and deliver audit strategies and capabilities for applicable therapeutic program level(s)
- Conduct GCP audits & support GxP Audits
- Develop tactical and operational audit plans to implement and deliver domain-specific audit strategies
- Independently lead and manage the domain-specific compliance audit programs
- Serve as the primary contact for applicable Clinical QA domain specific activities
Requirements
What you’ll need- A minimum of a bachelor’s or equivalent University degree
- 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- Inclusive work environment
- Professional development opportunities