Associate Dir. Cross TA Risk Management
Johnson & Johnson
August 20, 2026
On-site
Titusville, NJ
Corporate Functions
Associate Director, Cross Therapeutic Area Clinical Risk Management (R&D Quality CRM)
Job Description
Works with trial and/or Program teams to coordinate identification, assessment, and mitigation of quality risks impacting trial data integrity, patient safety/well-being, or rights. Executes data-driven, risk-based trial oversight to deliver quality, compliance with regulatory/internal procedures, and inspection readiness.
Key Responsibilities
- Independently contribute to identification/assessment of key protocol/set-up risks; advise on mitigation strategies for complex trials/compounds/programs.
- Lead regular review of risk areas with Risk Owners; assess mitigation progress; identify new risks/additional mitigation needs.
- Maintain Clinical Quality Plans (CQP) in the quality repository.
- Drive quality risk monitoring reviews; coach others.
- Communicate/facilitate risk updates via Quality Working Groups/Governance Fora.
- Highlight new potential systemic risks to RDQ CRM management.
- Ensure consistent interpretation of issues requiring quality investigations.
- Guide Significant Quality Issues (SQIs) per standards; escalate SQIs to senior R&D management.
- Advise on CAPA Plans and Effectiveness Checks (Self-Identified, Inspection, Audit).
- Drive inspection readiness: develop inspection narratives, prepare sites, ensure availability of key documents/records, coordinate mock inspections with Regulatory Compliance.
- Support Investigator, Sponsor-Monitor, and third-party inspections (including post-inspection).
- Provide independent advice on research quality/compliance with Quality professionals/SMEs.
- Participate in working groups to develop/refine processes, tools, and systems for innovative quality solutions.
- Provide training/coaching as needed.
Qualifications
- Bachelor’s degree (scientific/medical/related) required.
- 8+ years in healthcare industry required.
- Proven GCP Quality and/or clinical trials experience required.
- Excellent oral/written interpersonal communication required.
- Flexibility for changing business needs.
- Ability to operate across culturally diverse/global structures required.
- Proficiency in Microsoft Office required.
- Fundamentals of clinical trial risk management required.
- Experience working to ICH guidelines required.
- Health Authority Inspection experience (FDA, EMA, other inspectorates) required.
Preferred
- Knowledge of GMP/GLP/GPvP.
- Strong project planning/management.
- Experience with escalations and CAPA support/advisement.
- Data analytics/visualization tools (e.g., Tableau, Spotfire) and data science/digital health (incl. RWE).
Benefits
Vacation, sick time, holiday pay (incl. floating holidays), work/personal/family time, parental leave, bereavement leave, caregiver leave, volunteer leave, military spouse time-off.
Travel
Up to 10% (primarily domestic, some international).
Job Description
Works with trial and/or Program teams to coordinate identification, assessment, and mitigation of quality risks impacting trial data integrity, patient safety/well-being, or rights. Executes data-driven, risk-based trial oversight to deliver quality, compliance with regulatory/internal procedures, and inspection readiness.
Key Responsibilities
- Independently contribute to identification/assessment of key protocol/set-up risks; advise on mitigation strategies for complex trials/compounds/programs.
- Lead regular review of risk areas with Risk Owners; assess mitigation progress; identify new risks/additional mitigation needs.
- Maintain Clinical Quality Plans (CQP) in the quality repository.
- Drive quality risk monitoring reviews; coach others.
- Communicate/facilitate risk updates via Quality Working Groups/Governance Fora.
- Highlight new potential systemic risks to RDQ CRM management.
- Ensure consistent interpretation of issues requiring quality investigations.
- Guide Significant Quality Issues (SQIs) per standards; escalate SQIs to senior R&D management.
- Advise on CAPA Plans and Effectiveness Checks (Self-Identified, Inspection, Audit).
- Drive inspection readiness: develop inspection narratives, prepare sites, ensure availability of key documents/records, coordinate mock inspections with Regulatory Compliance.
- Support Investigator, Sponsor-Monitor, and third-party inspections (including post-inspection).
- Provide independent advice on research quality/compliance with Quality professionals/SMEs.
- Participate in working groups to develop/refine processes, tools, and systems for innovative quality solutions.
- Provide training/coaching as needed.
Qualifications
- Bachelor’s degree (scientific/medical/related) required.
- 8+ years in healthcare industry required.
- Proven GCP Quality and/or clinical trials experience required.
- Excellent oral/written interpersonal communication required.
- Flexibility for changing business needs.
- Ability to operate across culturally diverse/global structures required.
- Proficiency in Microsoft Office required.
- Fundamentals of clinical trial risk management required.
- Experience working to ICH guidelines required.
- Health Authority Inspection experience (FDA, EMA, other inspectorates) required.
Preferred
- Knowledge of GMP/GLP/GPvP.
- Strong project planning/management.
- Experience with escalations and CAPA support/advisement.
- Data analytics/visualization tools (e.g., Tableau, Spotfire) and data science/digital health (incl. RWE).
Benefits
Vacation, sick time, holiday pay (incl. floating holidays), work/personal/family time, parental leave, bereavement leave, caregiver leave, volunteer leave, military spouse time-off.
Travel
Up to 10% (primarily domestic, some international).