Head of Quality North America

Roquette; Wilmington (DE); On-site; USD 173,000 - 234,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Leadership

Change management

Cross-functional collaboration

Lean / Operational Excellence

Education

Bachelor's degree in a relevant scientific or engineering discipline

Six Sigma Black Belt certification

Lean / Operational Excellence credentials

Job description

Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients. Want to help us make a difference? Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients. Each of our ingredients responds to unique and essential needs, and they enable healthier lifestyles. 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.
• 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 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.”

Roquette is proud to be a global company where you can find personal and professional growth through multiple diverse experiences. Roquette strives to create a dynamic workforce while remaining firmly committed to equal opportunity by complying with EEO laws. As we continue to grow, Roquette understands that to be successful we must always be inclusive in our approach. Visit www.roquette.com and www.sustainability.roquette.com for more information. Roquette is a global leader in sustainable plant‑based solutions, driving innovation and strong partnerships that are shaping the future of nutrition, health, and bioindustry. The company harnesses natural resources such as wheat, corn, seaweed, and cellulose to craft high‑performance ingredients used in everyday foods, oral medications, advanced biopharmaceuticals, and a range of bio‑based products. A family‑owned company with over 90 years of expertise and 11,000 employees, Roquette serves clients in over 150 countries and is committed to creating lasting value for customers, patients, consumers, and society. Together, we turn the potential of nature into the essentials of life. Discover more about Roquette here.