Global Quality Third Parties Leader Single Use System and Biological Raw Material
Sanofi
June 29, 2026
Remote friendly (Morristown, NJ)
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 all supplier sites and geographies
- Maintain an up-to-date supplier portfolio; ensure appropriate quality classification and tiering
- Define and monitor supplier quality performance; drive corrective actions for performance gaps
- Lead “Quality Alert” activities: coordinate rapid responses for critical supplier quality issues impacting manufacturing
- Assess supplier investigations and follow-up CAPA implementation
- Negotiate, draft, review, and maintain Quality Agreements with third-party SUS and BRM suppliers
- Oversee supplier-initiated change notifications impacting SUS/BRM quality; assess impacts on Quality Agreement, audits needs, QSMP, and QMS database; drive appropriate actions
- Coordinate management of critical changes with internal stakeholders; act as Sanofi “One Voice” to suppliers
- Serve as the primary quality interface with internal functions (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 quality metrics; lead continuous improvement and benchmark best practices
Basic Qualifications / Requirements
- Master’s degree in Engineering or science (or related fields)
- 10+ years in manufacturing operations or pharmaceutical quality roles
- Knowledge of QTP processes; experience leading cross-functional projects
- Ability to work cross-functionally in complex, matrix environments
- Strong communication and active listening; project management expertise in international settings
- Technical understanding of biopharmaceutical manufacturing systems
- Open-mindedness and agility (challenge status quo)
- English fluency required
Preferred Skills
- Veeva QTP knowledge
Benefits
- Health and wellbeing benefits including high-quality healthcare, prevention and 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 all supplier sites and geographies
- Maintain an up-to-date supplier portfolio; ensure appropriate quality classification and tiering
- Define and monitor supplier quality performance; drive corrective actions for performance gaps
- Lead “Quality Alert” activities: coordinate rapid responses for critical supplier quality issues impacting manufacturing
- Assess supplier investigations and follow-up CAPA implementation
- Negotiate, draft, review, and maintain Quality Agreements with third-party SUS and BRM suppliers
- Oversee supplier-initiated change notifications impacting SUS/BRM quality; assess impacts on Quality Agreement, audits needs, QSMP, and QMS database; drive appropriate actions
- Coordinate management of critical changes with internal stakeholders; act as Sanofi “One Voice” to suppliers
- Serve as the primary quality interface with internal functions (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 quality metrics; lead continuous improvement and benchmark best practices
Basic Qualifications / Requirements
- Master’s degree in Engineering or science (or related fields)
- 10+ years in manufacturing operations or pharmaceutical quality roles
- Knowledge of QTP processes; experience leading cross-functional projects
- Ability to work cross-functionally in complex, matrix environments
- Strong communication and active listening; project management expertise in international settings
- Technical understanding of biopharmaceutical manufacturing systems
- Open-mindedness and agility (challenge status quo)
- English fluency required
Preferred Skills
- Veeva QTP knowledge
Benefits
- Health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave