Associate Dir. Cross TA Risk Management
Johnson & Johnson
June 25, 2026
On-site
Horsham, PA
Operations
Associate Director, Cross Therapeutic Area Clinical Risk Management (R&D Quality CRM)
Role Description
Coordinates identification, assessment, and mitigation of quality risks impacting trial data integrity, patient safety/well-being/rights. Executes data-driven, risk-based oversight to ensure quality execution, regulatory/internal compliance, and inspection readiness.
Key Responsibilities
- Independently assess key protocol/set-up risks and advise mitigation strategies.
- Lead regular reviews with Risk Owners to track mitigation progress and identify new/additional risks.
- Maintain Clinical Quality Plans (CQP) in the quality repository for ongoing reviews.
- Drive quality risk monitoring reviews and coach others.
- Communicate risk updates via Quality Working Groups/Governance Fora.
- Support quality investigations interpretation; guide/significant quality issues escalation (SQI) to senior management.
- Advise on CAPA Plans and Effectiveness Checks.
- Drive inspection readiness (inspection narratives, site readiness, document/record availability, mock inspections with Regulatory Compliance).
- Support investigator/sponsor-monitor/third-party inspections (including post-inspection support).
- Provide independent guidance on research quality/compliance; contribute to cross-functional working groups and process/tool development.
- Train and coach peers/new employees.
Qualifications (Required)
- Bachelor’s degree (scientific/medical/related).
- 8+ years in healthcare industry.
- Strong GCP Quality and/or clinical trials experience.
- Excellent interpersonal, oral, and written communication.
- Flexibility; ability to work across culturally diverse/global structures.
- Proficiency in Microsoft Office.
- Clinical trial risk management fundamentals; experience with ICH guidelines.
- Health Authority Inspection experience (e.g., FDA/EMA/other inspectorates).
- Proficiency in English.
Qualifications (Preferred)
- Knowledge of GMP/GLP/GPvP.
- Project planning/management; escalation and CAPA support.
- Data analytics/visualization (Tableau/Spotfire or similar).
- Data Science/Digital Health (incl. RWE).
Travel: Up to 10%.
Benefits (time off)
- Vacation: 120 hrs/year; Sick time: 40 hrs/year (state-specific values noted).
- Holiday/Floating Holidays: 13 days/year.
- Work/Personal/Family Time: up to 40 hrs/year.
- Parental leave: 480 hrs; Bereavement leave: 240 hrs (immediate family) + 40 hrs (extended); Caregiver leave: 80 hrs/52-week rolling period; Volunteer leave: 32 hrs; Military spouse time-off: 80 hrs/year.
Application Instructions
Role may be posted under multiple requisition numbers by country; applications are considered a single submission (US R-083139; Switzerland R-085157; UK R-085163; Belgium/Madrid R-085167).
Role Description
Coordinates identification, assessment, and mitigation of quality risks impacting trial data integrity, patient safety/well-being/rights. Executes data-driven, risk-based oversight to ensure quality execution, regulatory/internal compliance, and inspection readiness.
Key Responsibilities
- Independently assess key protocol/set-up risks and advise mitigation strategies.
- Lead regular reviews with Risk Owners to track mitigation progress and identify new/additional risks.
- Maintain Clinical Quality Plans (CQP) in the quality repository for ongoing reviews.
- Drive quality risk monitoring reviews and coach others.
- Communicate risk updates via Quality Working Groups/Governance Fora.
- Support quality investigations interpretation; guide/significant quality issues escalation (SQI) to senior management.
- Advise on CAPA Plans and Effectiveness Checks.
- Drive inspection readiness (inspection narratives, site readiness, document/record availability, mock inspections with Regulatory Compliance).
- Support investigator/sponsor-monitor/third-party inspections (including post-inspection support).
- Provide independent guidance on research quality/compliance; contribute to cross-functional working groups and process/tool development.
- Train and coach peers/new employees.
Qualifications (Required)
- Bachelor’s degree (scientific/medical/related).
- 8+ years in healthcare industry.
- Strong GCP Quality and/or clinical trials experience.
- Excellent interpersonal, oral, and written communication.
- Flexibility; ability to work across culturally diverse/global structures.
- Proficiency in Microsoft Office.
- Clinical trial risk management fundamentals; experience with ICH guidelines.
- Health Authority Inspection experience (e.g., FDA/EMA/other inspectorates).
- Proficiency in English.
Qualifications (Preferred)
- Knowledge of GMP/GLP/GPvP.
- Project planning/management; escalation and CAPA support.
- Data analytics/visualization (Tableau/Spotfire or similar).
- Data Science/Digital Health (incl. RWE).
Travel: Up to 10%.
Benefits (time off)
- Vacation: 120 hrs/year; Sick time: 40 hrs/year (state-specific values noted).
- Holiday/Floating Holidays: 13 days/year.
- Work/Personal/Family Time: up to 40 hrs/year.
- Parental leave: 480 hrs; Bereavement leave: 240 hrs (immediate family) + 40 hrs (extended); Caregiver leave: 80 hrs/52-week rolling period; Volunteer leave: 32 hrs; Military spouse time-off: 80 hrs/year.
Application Instructions
Role may be posted under multiple requisition numbers by country; applications are considered a single submission (US R-083139; Switzerland R-085157; UK R-085163; Belgium/Madrid R-085167).