Head of Quality North America

RoquettePhiladelphia, PA
$172,938 - $234,110Hybrid

About The Position

Roquette is seeking a Head of Quality – North America (HPS) to lead and transform Quality across North America. This role involves deploying and embedding a harmonized One Roquette QMS, ensuring alignment across sites, consistency of practices, and measurable performance improvement. It is a transformation role focused on simplifying, standardizing, and elevating Quality performance, acting as a connector and change leader to drive adoption of global standards and build a high-performing, collaborative Quality network. The position is located in Newark, DE.

Requirements

  • Bachelor's degree or higher in a relevant scientific or engineering discipline
  • 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

Nice To Haves

  • Advanced degree preferred
  • Six Sigma Black Belt certification preferred
  • Lean / Operational Excellence credentials a plus
  • Familiarity with CAPEX project quality oversight preferred

Responsibilities

  • 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
  • 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
  • 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
  • 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 strong 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

Benefits

  • Performance-based incentive compensation
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