R & D Clinical Quality Strategy Lead - GCP (Billerica MA)

EMD Serono, Inc. - Billerica, MA

Hiring: R & D Clinical Quality Strategy Lead - GCP (Billerica MA) Company: EMD Serono, Inc. Location: Billerica, MA Job Posted Time: 2026-09-16 11:46:26 Employment Type: On-site Target Skills & Keywords : Embedded Systems, GCP, Quality Assurance, R, Risk Management, Root Cause Analysis, Stakeholder Management About the job Experience: •10 years of experience in Quality Assurance or a related pharmaceutical/biotech field. •Minimum 10 years of experience in Quality Assurance or a related pharmaceutical/biotech field. Required Skills: •As the R&D Quality Strategy Lead •Lead Program Quality Strategy •Develop and implement the quality strategy for assigned development programs. •Define and oversee risk assessments, program audit strategy and other QA activities. •Provide quality expertise during due diligence and key business decisions. •Support continuous improvement and quality-by-design approaches across programs. •Manage Risk and Compliance •Identify emerging quality risks, trends, and gaps. Qualifications: •Bachelor's degree in a scientific or quality-related field required; advanced degree preferred. •Strong knowledge of drug development processes and global GCP regulations. Compensation: •$142,200 - $213,300 / year •Position may be eligible for sales or performance-based bonuses 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!