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Catalent

Global contract drug formulation, manufacturing, packaging

Manager, Process Excellence

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeNo salary listed

About the Job

Requirements

  • A bachelor's degree in science, engineering, operations, supply chain, or a related field.
  • Relevant experience in clinical supply, Good Manufacturing Practice operations, process excellence, or business systems.
  • Knowledge of Good Practice regulations, Computer System Validation practices, Standard Operating Procedure authorship, and system lifecycle expectations.
  • Experience with system testing, User Acceptance Testing coordination, and requirement documentation.
  • Analytical and process-mapping skills, including the ability to simplify complex workflows.
  • Ability to manage multiple projects with tight deadlines.
  • Demonstrable leadership experience at Catalent, potentially including participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW, may be considered in place of external experience.

Responsibilities

  • Own and maintain global Standard Operating Procedures, work instructions, forms, and process documentation to ensure compliant and standardized clinical supply systems operations.
  • Act as the business owner for key clinical supply systems, managing process requirements, enhancements, and user support.
  • Gather, document, and approve business requirements, including User Requirement Specifications and Functional Requirement Specifications, for system changes and new functionality.
  • Coordinate and support system testing activities, including User Acceptance Testing, validation deliverables, and deployment readiness.
  • Provide guidance and troubleshooting support to site subject matter experts on process execution, system functionality, and issue resolution.
  • Deliver training, onboarding, and communications related to new processes, procedural updates, and system releases.
  • Monitor process performance metrics, identify improvement opportunities, and lead continuous improvement initiatives.
  • Collaborate with Quality, Information Technology, Operations, and site teams on harmonization, change control activities, compliance, and operational excellence.

Desired Qualifications

  • Experience with Catalent systems, including SFX, JDE, TrackWise/Global TrackWise, SIS/CCS, or ValGenesis.
  • Lean Six Sigma, process excellence, or business analysis credentials.
  • Experience writing Standard Operating Procedures or work instructions for system and non-system processes.
  • Experience as a system owner or process owner in a regulated environment.

About the Company

Catalent

Global contract drug formulation, manufacturing, packaging

Catalent provides end-to-end contract development and manufacturing services for pharmaceutical, biotechnology, and consumer health products. Its offerings cover drug formulation, large-scale manufacturing, clinical supply, and packaging under long-term partnerships, coordinating through a connected supply chain to move products from development to market. It differentiates itself with a broad, integrated service platform and long-standing customer relationships that help clients accelerate development and ensure reliable supply. The company aims to help clients bring products to market efficiently while balancing quality, cost, and sustainability across the product lifecycle.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Franklin Township, NJ
Founded
1996

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