Deputy Director of DS Manufacturing Quality Systems

Location: Pearl River

Job Title:

Deputy Director of DS Manufacturing Quality Systems

Location:

Pearl River, NY About the job As Deputy Director, Drug Substance (DS) Manufacturing Quality Systems at our Pearl River site, you'll lead and develop a broad Quality Systems organization — spanning Principal Investigators, Technical Writers, and Quality Systems Support Associates — responsible for the full lifecycle of manufacturing quality records: deviation investigations, CAPAs, effectiveness checks, periodic reviews, and QMS document updates.

You'll keep investigations on track, products moving, and patients supplied, all while driving a culture of continuous improvement and operational excellence. You'll be a key voice in audits and regulatory inspections, a coach to your team, and a connector across functions. If you thrive in a fast-paced, regulated environment where your decisions carry real business and patient impact, this role is for you.

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world.

Together, we chase the miracles of science to improve people's lives. Main responsibilities Lead and develop an agile Quality Systems team — including Principal Investigators, Technical Writers, and Quality Systems Support Associates — coordinating work assignments to meet fluctuating business needs while sustaining a strong learning and development culture Own on-time closure of Drug Substance Manufacturing deviation investigations, CAPAs, effectiveness checks, and periodic reviews of departmental quality documents to meet site performance metrics and product release timelines Identify and resolve roadblocks by coordinating with support groups to ensure the Manufacturing Quality System Matrix remains current and comprehensive Review deviations, CAPAs, and other quality records for completeness, and conduct management-level review of minor, major, and critical events ahead of Quality Assurance review Oversee timely and accurate document updates within the Quality Management System (QMS), ensuring documentation remains current, compliant, and audit-ready Coach and develop the Quality Systems team, providing continuous feedback and challenging growth opportunities while reinforcing Sanofi's culture, values, and cGMP compliance standards Lead cross-functional engagement with key stakeholders (Manufacturing, Quality Control, Manufacturing Technology, Sterility Assurance, and Quality Assurance) to build consensus and drive timely closure of quality records Partner closely with the Head of Quality Assurance Operations and Inspection Readiness to align quality systems execution with site-wide QA strategy, audit readiness, and regulatory compliance priorities Serve as the site representative during internal and external audits and regulatory inspections, confidently defending investigation write-ups and quality documentation on behalf of the team Champion a continuous improvement culture by identifying and driving new tools, process changes, and cost-reduction initiatives that reduce deviations and improve cycle time efficiency across the Quality System Communicate progress, updates, and escalations accurately and effectively — in writing and verbally — across multiple levels of the organization and to regulatory agencies Ensure all Quality System operations are conducted in full…