External Quality Lead

GlaxoSmithKline

Cambridge, MA, USA
Base: $99,825 to $166,375; bonus/equity: annual bo...
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Quality agreement negotiations
Gmp training for contractors
Risk management tools
** GlaxoSmithKline is seeking an External Quality Lead to oversee quality compliance in Contract Manufacturing Organizations (CMOs) to ensure the integrity of their pharmaceutical products. The role involves managing relationships with CMOs, monitoring performance, and ensuring regulatory compliance while working in a hybrid environment. **

Job Summary

  • This position is responsible for the Quality oversight of assigned Contract Manufacturing Organisations (CMOs) in an External Manufacturing specific Region to ensure MAH’s product quality, compliance and reputation is protected.
  • Partner with GSK functions, such as EM Procurement, Quality, Technical and Supply (PQTS+) to assure that potential quality and compliance issues are identified, communicated and promptly resolved in order to assure a secure source of supply of quality product.
  • The annual base salary for new hires in this position ranges $99,825 to $166,375, in addition to an annual bonus and eligibility to participate in our share based long term incentive program.

Matching Summary

Match Score: 75

** GlaxoSmithKline is seeking an External Quality Lead to oversee quality compliance in Contract Manufacturing Organizations (CMOs) to ensure the integrity of their pharmaceutical products. The role involves managing relationships with CMOs, monitoring performance, and ensuring regulatory compliance while working in a hybrid environment. **

Salary

Base: $99,825 to $166,375; Bonus/Equity: annual bonus and long term incentive program; Benefits: health care, insurance, retirement, paid holidays, vacation, paid caregiver/parental and medical leave

Skills & Requirements

Must-have

  • Quality Agreement negotiations
  • GMP training for contractors
  • Risk management tools
  • Quality Systems performance management
  • Batch record review and disposition

Nice-to-have

  • Ability to adapt and anticipate issues
  • Commercial acumen
  • Intercultural skills
  • Demonstrated sense of urgency
  • Ability to work independently

Key Requirements

  • Science Degree with pharmaceutical manufacturing experience
  • Experience in Technical and/or Operational Quality roles
  • Experience managing and leading Quality teams
  • Experience with Change Management
  • Project management experience

Work Rights

Not specified

Tailored Resume

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