External Quality Small Molecule Americas Lead

GSK

**
Bachelor's degree in science
Cgmp requirements experience
Pharmaceutical manufacturing quality operations
** GSK is seeking an External Quality Small Molecule Americas Lead to oversee quality operations at Contract Manufacturing Organizations (CMOs) to ensure compliance and product quality. The role involves significant collaboration with internal and external stakeholders, focusing on quality agreement negotiations, performance management, and continuous improvement initiatives. **

Job Summary

  • This position is responsible for the Quality oversight of assigned Contract Manufacturing Organisations (CMOs) to ensure product quality, compliance, and reputation are protected.
  • The role requires leading Quality Agreement negotiations, managing regulatory information flow, and driving corrective actions based on KPIs like complaints and deviations.
  • GSK offers a comprehensive benefits program and a hybrid work arrangement requiring on-site presence 2 to 3 days per week.

Matching Summary

Match Score: 75

** GSK is seeking an External Quality Small Molecule Americas Lead to oversee quality operations at Contract Manufacturing Organizations (CMOs) to ensure compliance and product quality. The role involves significant collaboration with internal and external stakeholders, focusing on quality agreement negotiations, performance management, and continuous improvement initiatives. **

Skills & Requirements

Must-have

  • Bachelor's degree in science
  • cGMP requirements experience
  • pharmaceutical manufacturing quality operations
  • Technical Quality and Operational Quality roles
  • negotiating Quality Agreements with CMOs

Nice-to-have

  • Lean Six Sigma or operational excellence experience
  • data-driven decision making using risk-management
  • statistical analysis and data trending skills
  • bilingual in Spanish or Portuguese
  • project management coordination experience

Key Requirements

  • Bachelor's degree in science
  • Experience in Technical Quality roles
  • Experience in Operational Quality roles
  • Knowledge of cGMP regulations
  • Strong stakeholder management skills

Work Rights

Not specified

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