Global Quality Third Parties Leader Single Use System and Biological Raw Material
Sanofi
June 29, 2026
Remote friendly (Swiftwater, PA)
United States
$133,500 - $192,833.33 USD yearly
Corporate Functions
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 quality standards across supplier sites and geographies.
- Maintain the supplier portfolio, including appropriate quality classification and tiering.
- Define/monitor supplier quality performance and drive corrective actions for gaps.
- Lead Quality Alerts; coordinate rapid response to critical supplier quality issues.
- Assess supplier investigations and verify CAPA implementation.
- Negotiate, draft, review, and maintain Quality Agreements with third-party SUS/BRM suppliers.
- Oversee supplier-initiated change notifications affecting SUS/BRM quality; assess impacts to Quality Agreements, audit needs, QSMP, and QMS database.
- Coordinate critical change management with internal stakeholders; act as the primary “One Voice” to suppliers.
- Serve as the primary quality interface with internal teams (Manufacturing, Procurement, R&D, Regulatory Affairs, Supply Chain).
- Participate in cross-functional project teams for new product introductions, technology transfers, and SUS/BRM-involved process changes.
- Define, track, and report SUS/BRM quality metrics; lead continuous improvement and benchmark best practices.
Basic Qualifications:
- Master’s degree in Engineering/science (or related).
- 10+ years in pharmaceutical manufacturing operations/quality.
- Knowledge of QTP processes; experience leading cross-functional projects.
- Ability to work cross-functionally in complex matrix environments.
- Strong communication/active listening; project management expertise internationally.
- Technical understanding of biopharmaceutical manufacturing systems.
- Open-mindedness/agility (challenge status quo).
- English fluency required.
Preferred Skill:
- Veeva QTP knowledge.
Benefits (if part of posting):
- Health and wellbeing benefits; 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 quality standards across supplier sites and geographies.
- Maintain the supplier portfolio, including appropriate quality classification and tiering.
- Define/monitor supplier quality performance and drive corrective actions for gaps.
- Lead Quality Alerts; coordinate rapid response to critical supplier quality issues.
- Assess supplier investigations and verify CAPA implementation.
- Negotiate, draft, review, and maintain Quality Agreements with third-party SUS/BRM suppliers.
- Oversee supplier-initiated change notifications affecting SUS/BRM quality; assess impacts to Quality Agreements, audit needs, QSMP, and QMS database.
- Coordinate critical change management with internal stakeholders; act as the primary “One Voice” to suppliers.
- Serve as the primary quality interface with internal teams (Manufacturing, Procurement, R&D, Regulatory Affairs, Supply Chain).
- Participate in cross-functional project teams for new product introductions, technology transfers, and SUS/BRM-involved process changes.
- Define, track, and report SUS/BRM quality metrics; lead continuous improvement and benchmark best practices.
Basic Qualifications:
- Master’s degree in Engineering/science (or related).
- 10+ years in pharmaceutical manufacturing operations/quality.
- Knowledge of QTP processes; experience leading cross-functional projects.
- Ability to work cross-functionally in complex matrix environments.
- Strong communication/active listening; project management expertise internationally.
- Technical understanding of biopharmaceutical manufacturing systems.
- Open-mindedness/agility (challenge status quo).
- English fluency required.
Preferred Skill:
- Veeva QTP knowledge.
Benefits (if part of posting):
- Health and wellbeing benefits; at least 14 weeks’ gender-neutral parental leave.