Global Quality Third Parties Leader Single Use System and Biological Raw Material
Sanofi
22 days ago
Remote friendly (Framingham, MA)
United States
$133,500 - $192,833.33 USD yearly
Operations
Main Responsibilities
- Define, implement, and maintain the global quality strategy for third-party suppliers of single-use systems (SUS) and biological raw materials (BRM).
- Ensure consistent application of quality standards across sites and geographies; maintain an up-to-date supplier portfolio and quality classification/tiering.
- Define and monitor supplier quality performance; drive corrective actions for performance gaps.
- Lead quality alerts: coordinate rapid response to critical supplier quality issues; assess investigations and CAPA implementation; collaborate with Supply Chain/Procurement on alternative suppliers/mitigations while maintaining quality.
- Negotiate, draft, review, and maintain Quality Agreements with SUS/BRM suppliers.
- Oversee supplier-initiated change notifications impacting SUS/BRM quality; assess impacts on Quality Agreement, audits needs, QSMP, and QMS database; coordinate critical changes internally and act as “Sanofi One Voice” to suppliers.
- Serve as primary quality interface with internal functions (Manufacturing, Procurement, R&D, Regulatory Affairs, Supply Chain); support cross-functional projects (new product introductions, technology transfers, process changes).
- Define/track/report quality metrics; lead continuous improvement; benchmark and implement best practices.
Qualifications
- Master’s degree in Engineering or science (or related).
- 10+ years in pharmaceutical manufacturing operations or quality.
- Knowledge of QTP processes; experience leading cross-functional projects.
- Ability to work in complex, matrix environments; strong communication.
- Project management expertise in international settings.
- Technical understanding of biopharmaceutical manufacturing systems.
- Open-minded/agile; challenge status quo.
- Veeva QTP knowledge (plus).
- English fluency required.
Benefits (highlights)
- High-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Define, implement, and maintain the global quality strategy for third-party suppliers of single-use systems (SUS) and biological raw materials (BRM).
- Ensure consistent application of quality standards across sites and geographies; maintain an up-to-date supplier portfolio and quality classification/tiering.
- Define and monitor supplier quality performance; drive corrective actions for performance gaps.
- Lead quality alerts: coordinate rapid response to critical supplier quality issues; assess investigations and CAPA implementation; collaborate with Supply Chain/Procurement on alternative suppliers/mitigations while maintaining quality.
- Negotiate, draft, review, and maintain Quality Agreements with SUS/BRM suppliers.
- Oversee supplier-initiated change notifications impacting SUS/BRM quality; assess impacts on Quality Agreement, audits needs, QSMP, and QMS database; coordinate critical changes internally and act as “Sanofi One Voice” to suppliers.
- Serve as primary quality interface with internal functions (Manufacturing, Procurement, R&D, Regulatory Affairs, Supply Chain); support cross-functional projects (new product introductions, technology transfers, process changes).
- Define/track/report quality metrics; lead continuous improvement; benchmark and implement best practices.
Qualifications
- Master’s degree in Engineering or science (or related).
- 10+ years in pharmaceutical manufacturing operations or quality.
- Knowledge of QTP processes; experience leading cross-functional projects.
- Ability to work in complex, matrix environments; strong communication.
- Project management expertise in international settings.
- Technical understanding of biopharmaceutical manufacturing systems.
- Open-minded/agile; challenge status quo.
- Veeva QTP knowledge (plus).
- English fluency required.
Benefits (highlights)
- High-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.