Jobs · Research · Massachusetts

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

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