Associate Dir. Cross TA Risk Management

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

Job Description To Follow
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.

Key Responsibilities
- 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.

Qualifications (Required)
- 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).

Qualifications (Preferred)
- 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).

Benefits (as listed)
- 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.

Application Instructions
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).