Senior RBQM Quality Leader for CtQ & Risk

Downtown Boulder Partnership; Madison (NJ); On-site; USD 163,850 - 198,543; Full time

Benefits offered by this job

Health Coverage including medical, pharmacy, dental, and vision care

401(k) plan and financial protection benefits

Flexible time off (unlimited, with manager approval)

Job summary

Downtown Boulder Partnership is seeking an Associate Director, RBQM - HOCT, ICN to be responsible for developing the Quality Narrative at the study levels. The role involves ensuring effective risk management and compliance throughout the clinical trials lifecycle.

The ideal candidate has a strong background in quality management and at least 8 years of relevant experience, with proven problem-solving and analytical skills.

Qualifications

• Minimum 8+ years QA experience in quality management, biomedical science, clinical development, or regulatory compliance.
• Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes.

Responsibilities

• Develop the Quality Narrative for end-to-end risk-based quality management.
• Conduct quality assurance spot checks during trial conduct.
• Provide regulatory intelligence on current and upcoming regulations.

Skills

Risk Based Quality Management principles

Analytical skills

Communication Skills

Project Management

Education

B.S. and/or M.S. in Chemistry, Biology, Health or Quality related field

Job description

Downtown Boulder Partnership is seeking an Associate Director, RBQM - HOCT, ICN to be responsible for developing the Quality Narrative at the study levels. The role involves ensuring effective risk management and compliance throughout the clinical trials lifecycle.

The ideal candidate has a strong background in quality management and at least 8 years of relevant experience, with proven problem-solving and analytical skills.