Global Quality Third Parties Leader Single Use System and Biological Raw Material
Sanofi
June 29, 2026
Remote friendly (Framingham, MA)
United States
$133,500 - $192,833.33 USD yearly
Operations
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 supplier sites and geographies
- Maintain an up-to-date supplier portfolio and ensure appropriate quality classification and tiering
- Define and monitor supplier quality performance; drive corrective actions for performance gaps
- Lead quality alerts; coordinate rapid response to critical supplier quality issues impacting manufacturing
- Assess supplier investigations and follow up CAPA implementation; collaborate with Supply Chain/Procurement to identify alternative suppliers or mitigation strategies while maintaining quality standards
- 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 Agreements, audit needs, QSMP, and QMS database; drive appropriate actions
- Coordinate critical changes with internal stakeholders and act as “One Voice” to suppliers
- Serve as primary quality interface between suppliers and 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 quality metrics; lead continuous improvement; benchmark and implement SUS/BRM quality best practices
Qualifications & Skills:
- Master’s degree in Engineering or science discipline (or related)
- 10+ years in manufacturing operations and/or quality roles in a pharmaceutical environment
- Knowledge of QTP processes; experience leading cross-functional projects
- Proven ability to work cross-functionally in complex, matrix environments
- Strong communication and active listening; project management experience in international settings
- Technical understanding of biopharmaceutical manufacturing systems
- Open-minded/agile; ability to challenge status quo
- Veeva QTP knowledge (plus)
- English fluency required
- 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 supplier sites and geographies
- Maintain an up-to-date supplier portfolio and ensure appropriate quality classification and tiering
- Define and monitor supplier quality performance; drive corrective actions for performance gaps
- Lead quality alerts; coordinate rapid response to critical supplier quality issues impacting manufacturing
- Assess supplier investigations and follow up CAPA implementation; collaborate with Supply Chain/Procurement to identify alternative suppliers or mitigation strategies while maintaining quality standards
- 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 Agreements, audit needs, QSMP, and QMS database; drive appropriate actions
- Coordinate critical changes with internal stakeholders and act as “One Voice” to suppliers
- Serve as primary quality interface between suppliers and 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 quality metrics; lead continuous improvement; benchmark and implement SUS/BRM quality best practices
Qualifications & Skills:
- Master’s degree in Engineering or science discipline (or related)
- 10+ years in manufacturing operations and/or quality roles in a pharmaceutical environment
- Knowledge of QTP processes; experience leading cross-functional projects
- Proven ability to work cross-functionally in complex, matrix environments
- Strong communication and active listening; project management experience in international settings
- Technical understanding of biopharmaceutical manufacturing systems
- Open-minded/agile; ability to challenge status quo
- Veeva QTP knowledge (plus)
- English fluency required