Senior RBQM Leader, Clinical Quality & Risk

Dormont Manufacturing Co; Princeton (NJ); On-site; USD 190,000 - 205,000; Full time

Benefits offered by this job

401K with company match

Healthcare Benefits

Generous PTO

Tuition Assistance

Job summary

Kyowa Kirin is seeking an Associate Director, Clinical Quality Management in Princeton, NJ. This role involves leading the Risk-Based Quality Management framework across trials, ensuring compliance and effective risk oversight.

Applicants should have over 10 years of experience in Clinical Operations or Quality Management, with a strong emphasis on regulatory compliance, risk management, and the ability to collaborate cross-functionally. The position offers a salary between $190,000 to $205,000, plus extensive benefits.

Qualifications

• 10+ years of experience in Clinical Operations or Clinical Quality.
• Expertise in ICH-GCP and regulatory requirements.
• Demonstrated ability to lead risk management frameworks.

Responsibilities

• Lead the design and implementation of a holistic RBQM framework.
• Ensure compliance with GCP and regulatory requirements.
• Drive organizational learning via lessons learned from trials.

Skills

RBQM Leadership

Cross-functional collaboration

Audit preparation

Risk analytics

Education

Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health

Advanced degree in Clinical Research, Quality Management

Tools

RBQM tools

CTMS

Power BI

Job description

Kyowa Kirin is seeking an Associate Director, Clinical Quality Management in Princeton, NJ. This role involves leading the Risk-Based Quality Management framework across trials, ensuring compliance and effective risk oversight.

Applicants should have over 10 years of experience in Clinical Operations or Quality Management, with a strong emphasis on regulatory compliance, risk management, and the ability to collaborate cross-functionally. The position offers a salary between $190,000 to $205,000, plus extensive benefits.