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About the Role
As Deputy Director, Drug Substance (DS) Manufacturing Quality Systems at our Pearl River site, you'll lead and develop a broad Quality Systems organization responsible for the full lifecycle of manufacturing quality records. 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.
Responsibilities
- Lead and develop an agile Quality Systems team, 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.
- 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.
- 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.
- Lead cross-functional engagement with key stakeholders 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, defending investigation write-ups and quality documentation.
- Champion a continuous improvement culture by identifying and driving new tools, process changes, and cost-reduction initiatives.
- Communicate progress, updates, and escalations accurately and effectively across multiple levels of the organization and to regulatory agencies.
- Ensure all Quality System operations are conducted in full compliance with cGMPs.
- Available to work extended and flexible hours, including weekends, as business needs require.
Requirements
- Bachelor's degree in Life Sciences, engineering, Business or any related field.
- 7+ years of experience in a cGMP-regulated pharmaceutical or quality environment, with demonstrated experience leading cross-functional initiatives, projects, or quality systems.
- Strong track record making risk-based decisions independently and managing multiple high-priority, high-visibility deadlines in a dynamic setting.
- Demonstrated ability to lead cross-functional consensus-building with stakeholders across Quality Control, Manufacturing Technology, Sterility Assurance, and Quality Assurance.
- Excellent written and verbal communication skills, with the ability to engage and influence stakeholders across all levels of the organization and with regulatory agencies.
Skills
- Quality Systems
- Deviation Investigations
- CAPA Management
- Risk-Based Decision Making
- Cross-Functional Leadership
- Communication Skills
- cGMP Compliance
Location
- Pearl River, NY
Work Type
- Full-time
Experience Level
- 7+ years
Education Level
- Bachelor's degree
Salary/Compensations
- $113,250.00 - $163,583.33
Benefits
- High-quality healthcare
- Prevention and wellness programs
- At least 14 weeks’ gender-neutral parental leave
About the Company
- Sanofi is 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.
- We chase the miracles of science to improve people's lives.
- Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale.
- In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.
- We are committed to a culturally inclusive workforce.
Equal Opportunity
- Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.