DS Manufacturing Quality Systems Deputy Director

BioSpace; Pearl River (NY); On-site; USD 180,000 - 240,000; Full time

Job summary

Sanofi is seeking a Deputy Director of DS Manufacturing Quality Systems at the Pearl River, NY site. This role leads a broad Quality Systems organization responsible for deviations, CAPAs, reviews, and QMS documentation, ensuring audit readiness and cGMP compliance.

You will drive cross-functional collaboration and continuous improvement in a regulated, fast-paced environment. You will coach teams, partner with QA operations, and represent the site during audits and regulatory inspections,

Qualifications

• Bachelor's degree in Life Sciences, engineering, Business or related field.
• 7+ years of experience in a cGMP-regulated pharmaceutical or quality environment.
• Proven ability to lead cross-functional initiatives and projects.
• Strong track record making risk-based decisions independently.
• Excellent written and verbal communication across all levels and regulators.

Responsibilities

• Lead and develop an agile Quality Systems team spanning 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.
• Ensure QMS documents are current, compliant, and audit-ready across Quality System operations.
• Represent the site during internal and external audits and regulatory inspections, defending investigation write-ups and quality documentation.
• Drive continuous improvement initiatives and process changes to reduce deviations and improve cycle time efficiency.

Skills

Cross-functional leadership

Risk-based decision making

Communication skills

Education

Bachelor's degree in Life Sciences, engineering, Business or related field

Job description

Sanofi is seeking a Deputy Director of DS Manufacturing Quality Systems at the Pearl River, NY site. This role leads a broad Quality Systems organization responsible for deviations, CAPAs, reviews, and QMS documentation, ensuring audit readiness and cGMP compliance.

You will drive cross-functional collaboration and continuous improvement in a regulated, fast-paced environment. You will coach teams, partner with QA operations, and represent the site during audits and regulatory inspections,