Assoc Dir., Clinical Quality Mgmt. Lead
EMD Serono, Inc. · Billerica, MA · 1 mo ago
Research$122k–$203k/yrFull-time
Your Role
You drive risk-based quality planning, execution, and oversight — and contribute directly to the integrity and success of our clinical trials. You'll play a key part in strengthening quality standards and inspection readiness, working closely with Global Development Operations and cross-functional study teams to make a real difference.
Who You Are
- Minimum Qualifications: Bachelor's/Master's in Medical or Life Sciences (PhD preferred), 8+ years of clinical development/operations experience
- Preferred Qualifications: Deep expertise in QbD, clinical quality risk management & risk-based monitoring (ICH E6 R3), proven ability to lead GCP inspection readiness & support health authority inspections, strong analytical mindset to identify trends and drive quality/process improvements, excellent communication & influencing skills in complex, multinational matrix environments, track record of successful CRO/vendor management and 3rd party oversight, strong project & change management skills, ability to work independently in fast-paced settings
Pay Range
The pay range for this position is $122,200 - $202,900. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors.
What We Offer
- We are a diverse, inclusive, and flexible working culture
- Great opportunities for personal development and career advancement across the globe
- Health insurance, paid time off (PTO), retirement contributions, and other perquisites