Global Clinical Risk Manager – GCP & Inspection Readiness

Scorpion Therapeutics

Spring House (PA)

On-site

USD 120,000 - 170,000

Full time

4 days ago

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Job summary

Johnson & Johnson in the US seeks a Manager, Cross Therapeutic Area Clinical Risk Management within the R&D Quality CRM team to oversee risk management for global clinical trials, ensuring data integrity and patient safety. You will lead risk reviews, craft mitigation plans, and mentor teams, supporting inspection readiness and quality investigations across regions to uphold regulatory compliance.

This on-site role includes up to 10% travel and opportunities to influence global program quality

Qualifications

Bachelor’s degree in a scientific or medical discipline.
8+ years in healthcare or pharma industries with proven GCP quality/trial experience.
Strong communication skills.
Proficiency in Microsoft Office.
Experience with risk management fundamentals and working in regulated environments.

Responsibilities

identify, assess, and mitigate risks affecting data integrity, patient safety, and trial compliance;
lead risk reviews, develop risk mitigation strategies, and maintain Clinical Quality Plans;
support inspection readiness activities, including mock inspections and post-inspection follow-up;
provide guidance on quality investigations, CAPA development, and escalation of significant issues;
collaborate across global teams and ensure regulatory compliance per ICH, GxP, and relevant standards.