Associate Dir. Cross TA Risk Management
Johnson & Johnson
June 25, 2026
On-site
Raritan, NJ
Operations
Associate Director, Cross Therapeutic Area (TA) Clinical Risk Management (R&D Quality CRM)
Responsibilities:
- Coordinate identification, assessment, and mitigation of quality risks impacting trial data integrity, patient safety, wellbeing, and rights.
- Execute data-driven, risk-based clinical trial/program oversight to ensure quality execution, regulatory/internal compliance, and inspection readiness.
- Independently participate in study activities; identify/assess key protocol/set-up risks and advise on mitigation for complex trials/compounds/programs.
- Lead regular reviews of risk areas with Risk Owners to track mitigation progress, reduce risks, and identify new/additional mitigation needs.
- Maintain Clinical Quality Plans (CQP) in the quality repository to support progress reviews.
- Drive quality risk monitoring reviews and coach others.
- Communicate/facilitate risk updates via Quality Working Groups/Governance Fora.
- Develop consistent interpretation for issues requiring quality investigations.
- Provide guidance/escalate significant quality issues (SQI) and support CAPA plans and effectiveness checks.
- Drive inspection readiness: develop inspection narratives, prepare sites, ensure key documents/records availability, and coordinate mock inspections with Regulatory Compliance.
- Support Investigator/Sponsor-Monitor/third-party inspections (including post-inspection support).
- Provide independent advice on research quality/compliance; participate in cross-functional working groups to refine processes/tools.
- Provide training and coaching to peers and new employees.
Qualifications:
- Bachelor’s degree (scientific/medical/related) required.
- 8+ years healthcare industry experience required.
- Proven strong GCP Quality and/or clinical trials experience required.
- Excellent oral/written interpersonal communication; cross-functional collaboration.
- Flexibility, ability to operate in culturally diverse environments.
- Proficiency in Microsoft Office required.
- Clinical trial risk management fundamentals; ICH guidelines experience required.
- Health Authority Inspection experience (FDA/EMA/other) required.
- English proficiency required.
- Up to 10% travel.
Preferred:
- Knowledge of GMP/GLP/GPvP.
- Project planning/management.
- Escalations management and CAPA support.
- Data analytics/visualization (Tableau, Spotfire, etc.).
- Data Science and Digital Health (including RWE/RWD).
Benefits (time off): Vacation 120 hours/year; Sick time 40 hours/year (CO 48; WA 56); Holiday pay incl. Floating Holidays 13 days/year; Work/Personal/Family Time up to 40 hours/year; Parental Leave 480 hours; Bereavement Leave 240 hours (immediate) / 40 hours (extended); Caregiver Leave 80 hours (52-week rolling period); Volunteer Leave 32 hours; Military Spouse Time-Off 80 hours/year.
Responsibilities:
- Coordinate identification, assessment, and mitigation of quality risks impacting trial data integrity, patient safety, wellbeing, and rights.
- Execute data-driven, risk-based clinical trial/program oversight to ensure quality execution, regulatory/internal compliance, and inspection readiness.
- Independently participate in study activities; identify/assess key protocol/set-up risks and advise on mitigation for complex trials/compounds/programs.
- Lead regular reviews of risk areas with Risk Owners to track mitigation progress, reduce risks, and identify new/additional mitigation needs.
- Maintain Clinical Quality Plans (CQP) in the quality repository to support progress reviews.
- Drive quality risk monitoring reviews and coach others.
- Communicate/facilitate risk updates via Quality Working Groups/Governance Fora.
- Develop consistent interpretation for issues requiring quality investigations.
- Provide guidance/escalate significant quality issues (SQI) and support CAPA plans and effectiveness checks.
- Drive inspection readiness: develop inspection narratives, prepare sites, ensure key documents/records availability, and coordinate mock inspections with Regulatory Compliance.
- Support Investigator/Sponsor-Monitor/third-party inspections (including post-inspection support).
- Provide independent advice on research quality/compliance; participate in cross-functional working groups to refine processes/tools.
- Provide training and coaching to peers and new employees.
Qualifications:
- Bachelor’s degree (scientific/medical/related) required.
- 8+ years healthcare industry experience required.
- Proven strong GCP Quality and/or clinical trials experience required.
- Excellent oral/written interpersonal communication; cross-functional collaboration.
- Flexibility, ability to operate in culturally diverse environments.
- Proficiency in Microsoft Office required.
- Clinical trial risk management fundamentals; ICH guidelines experience required.
- Health Authority Inspection experience (FDA/EMA/other) required.
- English proficiency required.
- Up to 10% travel.
Preferred:
- Knowledge of GMP/GLP/GPvP.
- Project planning/management.
- Escalations management and CAPA support.
- Data analytics/visualization (Tableau, Spotfire, etc.).
- Data Science and Digital Health (including RWE/RWD).
Benefits (time off): Vacation 120 hours/year; Sick time 40 hours/year (CO 48; WA 56); Holiday pay incl. Floating Holidays 13 days/year; Work/Personal/Family Time up to 40 hours/year; Parental Leave 480 hours; Bereavement Leave 240 hours (immediate) / 40 hours (extended); Caregiver Leave 80 hours (52-week rolling period); Volunteer Leave 32 hours; Military Spouse Time-Off 80 hours/year.