Global Quality Third Parties Leader Single Use System and Biological Raw Material
Sanofi
21 days ago
Remote friendly (Swiftwater, PA)
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 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 alerts; coordinate rapid response to critical supplier quality issues impacting manufacturing.
- Assess supplier investigations and follow up CAPA implementation.
- When relevant, collaborate with Supply Chain and Procurement to identify alternative suppliers/mitigation strategies while maintaining quality standards.
- 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 the QMS database; drive appropriate actions.
- Coordinate management of critical changes with internal stakeholders; act as “One Voice” to suppliers.
- Serve as primary quality interface between third-party suppliers and 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
- Master’s degree in Engineering/science (or related).
- 10+ years in manufacturing operations/quality in pharma or related fields.
- 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.
- Veeva QTP knowledge (plus).
- English fluency required.
Benefits (explicitly stated)
- High-quality healthcare and prevention/wellness programs; 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 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 alerts; coordinate rapid response to critical supplier quality issues impacting manufacturing.
- Assess supplier investigations and follow up CAPA implementation.
- When relevant, collaborate with Supply Chain and Procurement to identify alternative suppliers/mitigation strategies while maintaining quality standards.
- 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 the QMS database; drive appropriate actions.
- Coordinate management of critical changes with internal stakeholders; act as “One Voice” to suppliers.
- Serve as primary quality interface between third-party suppliers and 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
- Master’s degree in Engineering/science (or related).
- 10+ years in manufacturing operations/quality in pharma or related fields.
- 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.
- Veeva QTP knowledge (plus).
- English fluency required.
Benefits (explicitly stated)
- High-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.