Associate Dir. Cross TA Risk Management
Johnson & Johnson
August 20, 2026
On-site
Spring House, PA
Corporate Functions
Associate Director, Cross Therapeutic Area Clinical Risk Management (R&D Quality CRM)
Key Responsibilities
- Coordinate identification, assessment, and mitigation of quality risks impacting clinical trial data integrity, patient safety, well-being, or rights.
- Execute data-driven, risk-based trial oversight to ensure quality execution, regulatory compliance, internal procedure adherence, and inspection readiness.
- Independently participate in study activities; identify/assess protocol set-up risks and advise on mitigation strategies.
- Lead regular reviews of risk areas with Risk Owners to track mitigation progress and identify new risks/additional mitigation needs.
- Maintain CQP (Clinical Quality Plans) in the quality repository for progress reviews.
- Drive quality risk monitoring reviews and coach others.
- Communicate/facilitate risk updates via Quality Working Groups and Governance Fora.
- Identify potential systemic risks; develop consistent interpretation of issues requiring quality investigations.
- Guide significant quality issues (SQI) and escalate SQI to senior R&D management.
- Advise on CAPA plan and effectiveness checks (Self-Identified, Inspection, Audit).
- Drive inspection readiness: develop inspection narratives, prepare sites (including pre-inspection support), ensure key document/record availability, and coordinate mock inspections with Regulatory Compliance.
- Support Investigator, Sponsor-Monitor, and third-party inspections (including post-inspection support).
- Provide independent advice on research quality/compliance; ensure consistent interpretation of international regulations/policy.
- Participate in clinical risk management and cross-functional/cross-sector working groups to refine processes/tools/systems.
- Provide training and coaching as needed.
Qualifications
- Bachelor’s degree (scientific, medical, or related) required.
- 8+ years in healthcare industry required.
- Proven strong GCP Quality and/or clinical trials experience required.
- Excellent interpersonal and oral/written communication required.
- Flexibility for changing business needs required.
- Demonstrated ability to operate across culturally diverse/regional/global structures required.
- Proficient in Microsoft Office required.
- Clinical trial risk management fundamentals required.
- Experience with ICH guidelines required.
- Health Authority Inspection experience (FDA, EMA, and others) required.
- English speaking/writing proficiency required.
- Up to 10% travel (primarily domestic) required.
Preferred Skills
- Knowledge of GMP, GLP, and/or GPvP.
- Strong project planning/management.
- Experience with escalations and CAPA support/advisement.
- Data analytics/data visualization (e.g., Tableau, Spotfire).
- Data Science and Digital Health (incl. RWE/Real World Disease).
Key Responsibilities
- Coordinate identification, assessment, and mitigation of quality risks impacting clinical trial data integrity, patient safety, well-being, or rights.
- Execute data-driven, risk-based trial oversight to ensure quality execution, regulatory compliance, internal procedure adherence, and inspection readiness.
- Independently participate in study activities; identify/assess protocol set-up risks and advise on mitigation strategies.
- Lead regular reviews of risk areas with Risk Owners to track mitigation progress and identify new risks/additional mitigation needs.
- Maintain CQP (Clinical Quality Plans) in the quality repository for progress reviews.
- Drive quality risk monitoring reviews and coach others.
- Communicate/facilitate risk updates via Quality Working Groups and Governance Fora.
- Identify potential systemic risks; develop consistent interpretation of issues requiring quality investigations.
- Guide significant quality issues (SQI) and escalate SQI to senior R&D management.
- Advise on CAPA plan and effectiveness checks (Self-Identified, Inspection, Audit).
- Drive inspection readiness: develop inspection narratives, prepare sites (including pre-inspection support), ensure key document/record availability, and coordinate mock inspections with Regulatory Compliance.
- Support Investigator, Sponsor-Monitor, and third-party inspections (including post-inspection support).
- Provide independent advice on research quality/compliance; ensure consistent interpretation of international regulations/policy.
- Participate in clinical risk management and cross-functional/cross-sector working groups to refine processes/tools/systems.
- Provide training and coaching as needed.
Qualifications
- Bachelor’s degree (scientific, medical, or related) required.
- 8+ years in healthcare industry required.
- Proven strong GCP Quality and/or clinical trials experience required.
- Excellent interpersonal and oral/written communication required.
- Flexibility for changing business needs required.
- Demonstrated ability to operate across culturally diverse/regional/global structures required.
- Proficient in Microsoft Office required.
- Clinical trial risk management fundamentals required.
- Experience with ICH guidelines required.
- Health Authority Inspection experience (FDA, EMA, and others) required.
- English speaking/writing proficiency required.
- Up to 10% travel (primarily domestic) required.
Preferred Skills
- Knowledge of GMP, GLP, and/or GPvP.
- Strong project planning/management.
- Experience with escalations and CAPA support/advisement.
- Data analytics/data visualization (e.g., Tableau, Spotfire).
- Data Science and Digital Health (incl. RWE/Real World Disease).