QMS Manager

QMS Manager - Sterile Pharmaceutical Manufacturing

We're partnering with a growing pharmaceutical manufacturer expanding their sterile manufacturing operations in South Florida. They are looking to bring on a hands-on QMS Manager to support and strengthen quality systems across a live GMP environment producing injectable products.This is a high-impact role within a developing site, offering strong ownership and exposure as the organization builds toward future regulatory readiness.

What you'll be doing:

• Own and manage deviations, CAPAs, change controls, and investigations
• Drive QMS improvements and system effectiveness across the site
• Partner with Manufacturing, QC, and Engineering to resolve quality events
• Support batch record review and product release activities
• Maintain documentation and systems in platforms such as TrackWise, Veeva, or similar
• Support audit and inspection readiness efforts
  
  

What we're looking for:

• ~5-8 years of experience in Quality Assurance within a GMP environment
• Strong hands-on experience with deviations, CAPAs, and investigations
• Background supporting pharmaceutical manufacturing operations
• Experience working cross-functionally with production and lab teams
• Solid understanding of GMP, data integrity, and documentation practices
  
  

Nice to have:

• Experience in sterile or injectable manufacturing environments
• Exposure to FDA inspections or audit readiness efforts
• Experience owning or improving QMS systems
  
  

Additional details:

• Location: Boca Raton, FL
• Schedule: Fully onsite, 5 days per week
• Compensation: Competitive base salary + bonus
• Open to candidates eligible to work in the U.S., including H1B transfers