Associate Dir. Cross TA Risk Management

Associate Director, Cross Therapeutic Area (TA) Clinical Risk Management — R&D Quality CRM.

Coordinate identification, assessment, and mitigation of quality risks impacting trial data integrity, patient safety, well‑being, and rights; execute data‑driven, risk‑based oversight; support quality execution, regulatory compliance, and inspection readiness.

• Identify and assess key clinical protocol/set‑up risks; advise on mitigations.
• Lead regular review of risk areas with Risk Owners; track mitigation progress; identify new risks.
• Maintain Clinical Quality Plans (CQP) in quality repository.
• Drive quality risk monitoring reviews and coach others.
• Communicate risk updates via Quality Working Groups and Governance Fora.
• Highlight systemic risks; ensure consistent interpretation of quality investigation issues.
• Guide significant quality issues (SQI) and escalate to senior R&D management.
• Advise on CAPA plans and Effectiveness Checks (self‑identified, inspection, audit).
• Drive inspection readiness (inspection narratives, site readiness, documents/records; coordinate mock inspections).
• Support investigator/sponsor‑monitor/third‑party inspections (including post‑inspection).
• Provide independent advice on research quality/compliance; participate in cross‑functional working groups.
• Train and coach peers/new employees.

• Bachelor’s degree (scientific/medical/related).
• 8+ years in healthcare industry.
• Strong GCP Quality and/or clinical trials experience.
• Interpersonal and oral/written communication skills.
• Flexibility; ability to work across culturally diverse styles.
• Microsoft Office proficiency.
• Clinical trial risk management fundamentals.
• ICH guidelines experience.
• Health Authority Inspection experience (FDA/EMA/other).
• Proficiency speaking and writing English.
• Up to 10% travel (primarily domestic).

• Knowledge of GMP/GLP/GPvP.
• Strong project planning/management; escalation and CAPA support.
• Data analytics/visualization tools (Tableau/Spotfire or similar).
• Data science/digital health (incl. RWE/RWD).

• Vacation: 120 hours/year;
  Sick time: 40 (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 (immediate) / 40 (extended);
  Caregiver Leave: 80 hours (52-week rolling);
  Volunteer Leave: 32 hours;
  Military Spouse Time-Off: 80 hours/year.

Role may be posted under multiple requisition numbers; applications are considered a single submission—apply to the country-specific posting(s) aligned with preferred location(s).