North America Quality Transformation Leader

Roquette; Wilmington (DE); Sur place; USD 173 000 - 234 000; Plein temps

Résumé du poste

Roquette in Newark, DE, is seeking a Head of Quality – North America to lead a regional Quality transformation across pharma, food, and excipients. You will deploy a harmonized QMS, drive Lean adoption, and build a high-performing quality network across sites.

You will shape the quality strategy, lead cross-functional teams, and ensure product release readiness while maintaining regulatory compliance and continuous improvement across North America.

Qualifications

• Bachelor's degree or higher in a relevant scientific or engineering discipline; advanced degree preferred.
• Six Sigma Black Belt certification preferred; Lean / Operational Excellence credentials a plus.
• Minimum of 10 years' quality leadership experience in pharma, pharma supplier regulated industries, or CDMO environments.

Responsabilités

• Own product release across all North America sites, ensuring safety and regulatory compliance.
• Lead a connected regional Quality network and drive continuous improvement.
• Develop and deploy the North America Quality strategy and the global QMS rollout.
• Drive Lean / Operational Excellence initiatives and reduce waste in processes.
• Lead internal and external audits and oversee CAPEX project quality oversight.
• Develop the regional Operational Quality network and ensure strong QA/QC performance.

Connaissances

Leadership

Change management

Cross-functional collaboration

Lean / Operational Excellence

Formation

Bachelor's degree in a relevant scientific or engineering discipline

Six Sigma Black Belt certification

Lean / Operational Excellence credentials

Description du poste

Roquette in Newark, DE, is seeking a Head of Quality – North America to lead a regional Quality transformation across pharma, food, and excipients. You will deploy a harmonized QMS, drive Lean adoption, and build a high-performing quality network across sites.

You will shape the quality strategy, lead cross-functional teams, and ensure product release readiness while maintaining regulatory compliance and continuous improvement across North America.