Hiring: Assoc Dir., Clinical Quality Mgmt. Lead Company: EMD Serono, Inc. Location: Billerica, MA Job Posted Time: 2026-09-10 11:46:26 Target Skills & Keywords : Change Management, GCP, Risk Management, Vendor Management About the job Experience: •8+ years of clinical development/operations experience Qualifications: •Bachelor's/Master's in Medical or Life Sciences (PhD preferred), 8+ years of clinical development/operations experience •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 Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!