North America Quality Transformation Leader

Roquette Group; Newark (DE); Hybrid; USD 173,000 - 234,000; Full time

Job summary

Roquette Group is seeking a Head of Quality - North America to transform quality across the region from Newark, DE. You will lead the harmonized QMS rollout, drive Lean transformation, and build a high-performing regional Quality network across sites with strong cross-functional collaboration.

The role requires 10+ years in quality leadership within pharma or regulated industries, with proven ability to standardize processes, influence across matrixed teams, and deliver measurable improvements.

Qualifications

• Bachelor’s degree or higher in a scientific or engineering discipline.
• Six Sigma Black Belt certification preferred; Lean / Operational Excellence credentials a plus.

Responsibilities

• Own product release across all North America sites.
• Guarantee product safety and regulatory compliance.
• Deploy and embed the Quality roadmap.
• Drive alignment across sites and teams to eliminate fragmentation.
• Lead a connected, high-performing Regional Quality network.
• Build a culture of continuous improvement, simplification, and customer focus.
• Lead the North America Quality strategy and roadmap.
• Drive transformation of Quality ways of working with Lean principles.
• Drive deployment of the global QMS roadmap across NA sites.
• Connect sites and teams to share best practices and resolve inconsistencies.
• Foster cross-site collaboration and One Roquette mindset.
• Lead deployment of Lean / Operational Excellence methodologies.
• Act as a Black Belt-level change agent to simplify processes and reduce waste.
• Improve cycle times (CAPA, deviations, release, complaints).
• Roll out tools, training, and coaching to site Quality teams.
• Embed continuous improvement into daily operations.
• Lead and develop the Regional Operational Quality network.
• Ensure QA and QC performance, including product release and lab efficiency.
• Drive standardization and best practice sharing.
• Ensure high-quality, timely response to customer requirements and complaints.
• Improve end-to-end customer quality journey.
• Collaborate with Sales and Customer Care.
• Ensure audit readiness and inspection performance.
• Lead internal and external audits.
• Act as Regional Crisis Leader for product-related issues.
• Build and develop a high-performing Quality leadership team.
• Develop Lean and problem-solving capabilities across the network.
• Drive quality culture, ownership, and accountability.
• Promote transparency and benchmarking across sites.
• Ensure appropriate oversight of third-party suppliers.
• Represent Roquette in industry forums and associations, especially IPEC.
• Ensure CAPEX projects meet Quality and regulatory requirements.
• Embed Quality by design in investments.

Skills

Leadership

Cross-functional collaboration

Lean / Six Sigma

Change management

Quality transformation

GxP / Regulatory

Education

Bachelor's degree or higher in scientific/engineering

Six Sigma Black Belt certification

Job description

Roquette Group is seeking a Head of Quality - North America to transform quality across the region from Newark, DE. You will lead the harmonized QMS rollout, drive Lean transformation, and build a high-performing regional Quality network across sites with strong cross-functional collaboration.

The role requires 10+ years in quality leadership within pharma or regulated industries, with proven ability to standardize processes, influence across matrixed teams, and deliver measurable improvements.