Deputy Director of DS Manufacturing Quality Systems

Job Title:

Deputy Director of DS Manufacturing Quality Systems

Location:

Pearl River, NY

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.

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.

• 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 compliance with…