Senior Manager, Quality Assurance- Medical Device & Combination Products

Gilead Sciences

La Verne, California, United States
Base: $143,225.00 - $185,350.00; bonus/equity: dis...
Hands-on experience with pre-filled syringe manufacturing
Iso 13485 regulatory compliance knowledge
Sterile drug product manufacturing expertise
This role is critical to ensuring a high-quality standard for product quality, regulatory compliance, and industry best practices for medical device and combination products

Job Summary

  • This role is critical to ensuring a high-quality standard for product quality, regulatory compliance, and industry best practices for medical device and combination products.
  • The ideal candidate brings hands-on experience in medical device and combination product quality, including ISO 13485, sterile drug product manufacturing, and device container-closure systems.
  • Gilead offers a competitive salary range of $143,225.00 - $185,350.00 along with discretionary annual bonuses, stock-based incentives, and comprehensive benefits packages.

Matching Summary

This role is critical to ensuring a high-quality standard for product quality, regulatory compliance, and industry best practices for medical device and combination products.

Salary

Base: $143,225.00 - $185,350.00; Bonus/Equity: Discretionary annual bonus and stock-based long-term incentives; Benefits: Company-sponsored medical, dental, vision, and life insurance plans

Skills & Requirements

Must-have

  • Hands-on experience with pre-filled syringe manufacturing
  • ISO 13485 regulatory compliance knowledge
  • Sterile drug product manufacturing expertise
  • Container-closure integrity assessment skills
  • GMP-regulated environment leadership

Nice-to-have

  • Experience with autoinjectors and co-packaged kits
  • Knowledge of ISO 14971 risk management tools
  • Familiarity with FDA device inspections
  • Project management and process improvement skills
  • Matrixed fast-paced environment adaptability

Key Requirements

  • Master's degree in Science or Engineering with 6+ years experience
  • Bachelor's degree in Science or Engineering with 8+ years experience
  • Direct hands-on experience with medical device manufacturing or QA
  • Strong working knowledge of ISO 13485 and ISO 14971

Work Rights

Not specified

Tailored Resume

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