Associate Director / Device Lead

GSK

Cambridge, MA, US
Base: $142,725 to $237,875; bonus/equity: annual b...
Bachelor's or master's degree in engineering or science
10+ years experience in medical device manufacturing
Knowledge of fda 21 cfr 820 and eu mdr regulations
The role serves as the technical owner globally accountable for Device delivery into GSK Manufacturing sites from the Supply Base

Job Summary

  • The role serves as the technical owner globally accountable for Device delivery into GSK Manufacturing sites from the Supply Base.
  • Candidates must ensure global device manufacturing processes are capable, efficient, and meet specifications while maintaining regulatory compliance.
  • The position offers a competitive annual base salary ranging from $142,725 to $237,875 along with bonus eligibility and comprehensive benefits.

Matching Summary

The role serves as the technical owner globally accountable for Device delivery into GSK Manufacturing sites from the Supply Base.

Salary

Base: $142,725 to $237,875; Bonus/Equity: Annual bonus and share based long term incentive program; Benefits: Health care, retirement, paid holidays, vacation, and parental leave

Skills & Requirements

Must-have

  • Bachelor's or Master's degree in engineering or science
  • 10+ years experience in medical device manufacturing
  • Knowledge of FDA 21 CFR 820 and EU MDR regulations
  • Experience with ISO 13485 and ISO 14971 standards
  • Global asset lifecycle management expertise
  • Device design and regulatory DHF/Technical file maintenance

Nice-to-have

  • Strong interpersonal and leadership skills
  • Commitment to team-based culture
  • Working understanding of data science
  • Experience leading device groups in global matrix environment
  • Ability to prioritize and decide appropriate courses of action

Key Requirements

  • Bachelor's in engineering or Science Degree
  • 10+ years in Medical Device/pharmaceutical Manufacturing
  • Masters Degree with 5+ years experience (alternative)
  • GMP and regulatory environment experience
  • US work authorization required for listed locations

Work Rights

Not specified

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