Head of Quality North America

We are looking for our next Head of Quality - North America (HPS) within our Health & Pharma Solutions team. The Head of Quality will lead and transform Quality across North America by deploying and embedding a harmonized One Roquette QMS, ensuring alignment across sites, consistency of practices, and measurable performance improvement. This is not a compliance role - it is a transformation role to simplify, standardize, and elevate Quality performance across North America, acting as a connector and change leader, driving adoption of global standards and building a high-performing, collaborative Quality network.

This position is located in Newark, DE.

Compensation:

The current salary range for this role is estimated to be $172,938 - $234,110. In addition, this position may also be eligible to earn performance-based incentive compensation. The specific compensation offered to a candidate will be influenced by a variety of factors including but not limited to skills, qualifications, experience, and location.

What You’ll Do:

Accountability & Quality Oversight

• Own product release across all sites within the North America Region
• Guarantee product safety and regulatory compliance (Pharma, Food, Feed as applicable)
• Ensure full deployment and consistent application of the Quality roadmap
• Drive alignment across all sites and teams to eliminate fragmentation
• Lead a connected, high-performing Regional Quality network
• Build a culture of continuous improvement, simplification, and customer focus

Quality Strategy & Transformation

• Lead the North America Quality strategy and roadmap
• Contribute actively to HPS global Quality strategy and standards
• Drive transformation of Quality ways of working, embedding Lean principles across the Region

QMS Rollout, Alignment & Network Leadership

• Drive deployment and adoption of the global QMS roadmap across all North America sites
• Ensure consistency of interpretation and execution of standards, processes, and tools
• Connect sites and teams to share best practices and resolve inconsistencies
• Foster cross-site collaboration and a One Roquette mindset
• Challenge unnecessary site-specific ways of working

Operational Excellence & Continuous Improvement

• 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

Operational Quality Leadership

• Lead and develop the Regional Operational Quality network
• Ensure strong QA and QC performance, including product release and lab efficiency
• Drive standardization and best practice sharing

Customer Quality

• Ensure high-quality, timely response to customer requirements and complaints
• Improve end-to-end customer quality journey
• Collaborate with Sales and Customer Care

Audit, Compliance & Crisis Management

• Ensure audit readiness and inspection performance
• Lead internal and external audits
• Act as Regional Crisis Leader for product-related issues

People & Network Leadership

• 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

External & Supplier Quality

• Ensure appropriate oversight of third-party suppliers
• Represent Roquette in industry forums and associations, especially IPEC

CAPEX & Compliance

• Ensure CAPEX projects meet Quality and regulatory requirements
• Embed Quality by design in investments

What You’ll Need:

Education:

• 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

Experience:

• Minimum of 10 years' experience in Quality leadership within pharma, pharma supplier regulated industries, or CDMO environments
• Proven multi-site / regional leadership experience across geographies and functions
• Demonstrated ability to influence and drive change across complex, matrixed organizations
• Track record of driving Quality transformation and building high-performing networks
• Strong Lean / Operational Excellence expertise with hands-on deployment experience
• Experience working cross-functionally with Sales, Customer Care, Operations, and Regulatory teams.
• Strong leadership, coaching, and organizational development skills.
• Experience managing third-party/contract manufacturing quality compliance.
• Familiarity with CAPEX project quality oversight preferred.

Supervisory Responsibility

• This role has 4 direct reports and is responsible for the broader Operational Quality network across North America.

Work Environment

• This role spends approximately 50% of the time in an office environment and 50% of the time in the plant environment.

Physical Demands

• While performing the duties of this job, the employee is required to speak or hear. The employee is frequently required to stand; walk, climb stairs, use hands and fingers to handle or feel; and reach with hands and arms; work in hot, cold and loud environments. Employee must be able to wear a respirator.

Position Type/Expected Hours of Work

• This is a full-time position. Days and flexible hours of work are required to meet facility demands.

Business Travel:

• Travel will be required when working on projects at other manufacturing plants (currently US, Canada, Brazil).
• Occasional international travel may be expected.

AAP/EEO Statement

Roquette is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law. "AAP, EEO, Drug-Free Workplace"

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.