Global Quality Third Parties Leader Single Use System and Biological Raw Material

Responsibilities:
- Define, implement, and maintain global quality strategy for third-party suppliers of single-use systems (SUS) and biological raw materials (BRM).
- Ensure consistent application of quality standards across supplier sites and geographies.
- Maintain supplier portfolio; ensure appropriate quality classification and tiering.
- Define/monitor supplier quality performance and drive corrective actions for performance gaps.
- Lead “quality Alert”; coordinate rapid response to critical supplier quality issues impacting manufacturing.
- Assess supplier investigations and follow-up CAPA implementation.
- Negotiate, draft, review, and maintain Quality Agreements with SUS and BRM suppliers.
- Oversee supplier-initiated change notifications impacting SUS/BRM quality; assess impacts on Quality Agreements, audit needs, QSMP, and QMS database; coordinate critical changes as “Sanofi One Voice.”
- Act as primary quality interface with internal teams (Manufacturing, Procurement, R&D, Regulatory Affairs, Supply Chain).
- Participate in cross-functional teams for new product introductions, technology transfers, and process changes involving SUS/BRM.
- Define, track, and report SUS/BRM quality metrics; lead continuous improvement and benchmark best practices.

Qualifications:
- Master’s degree in Engineering or science (or related fields).
- 10+ years in pharmaceutical manufacturing operations and/or Quality roles.
- Knowledge of QTP processes; experience leading cross-functional projects.
- Ability to work in complex, matrix environments.
- Strong communication and active listening; international project management experience.
- Technical understanding of biopharmaceutical manufacturing systems.
- Open-minded/agile; challenge status quo.
- Veeva QTP knowledge (plus).
- English fluency required.

Benefits:
- High-quality healthcare, prevention and wellness programs; at least 14 weeks’ gender-neutral parental leave.