Senior Clinical Audit Program Manager

BD

Franklin Lakes, NJ, USA
Base: $166,153.85 - $265,846.15 usd annual; bonus:...
Fully remote
Clinical research quality audits
Powerbi dashboard development
Capa and root cause investigation

Salary

Base: $166,153.85 - $265,846.15 USD Annual; Bonus: 15% Annual Potential + $26,000 Discretionary LTI; Benefits: Comprehensive health, dental, vision, 401(k), wellness programs

Skills & Requirements

Must-have

  • Clinical Research Quality Audits
  • PowerBI Dashboard Development
  • CAPA and Root Cause Investigation
  • ISO 13485 and ISO 14155 Compliance
  • Lead Auditor Certification
  • MedTech Regulatory Standards

Nice-to-have

  • Collaborative leadership style
  • Continuous improvement mindset
  • Advanced degree in life sciences
  • Study management experience
  • Diagnostic trial background

Key Requirements

  • Bachelor's Degree in Life Sciences
  • Minimum 7 years clinical research experience
  • Minimum 5 years clinical auditing experience
  • Certified Quality Auditor or ISO Lead Auditor
  • Mastery of MedTech regulations (21 CFR 812, ISO 14971)
  • US work authorization required

Work Rights

Not specified

Tailored Resume

Cover Letter