QA Operations Lead

vor 2 Wochen

Geneva, Illinois, Schweiz Expertree Vollzeit

About the Role

We are looking for a
QA Operations Lead

with 5–10 years of GMP experience to support our manufacturing operations and ensure consistent quality oversight. You will play a central role in day-to-day compliance, batch review, deviation management, and inspection readiness. 

This position is ideal for someone who thrives in a fast-paced GMP environment and enjoys working closely with cross-functional teams on the production floor.

Responsibilities

  • Ensure on-floor QA presence to support daily operations
  • Review and approve GMP documentation, including deviations, CAPAs, change controls
  • Support batch review and batch disposition activities
  • Drive investigations and ensure robust root cause analysis
  • Maintain inspection readiness and support audits and regulatory inspections
  • Collaborate closely with Manufacturing, QC, Engineering, Supply Chain, and other functions
  • Contribute to continuous improvement initiatives and QMS enhancements
  • Ensure compliance with cGMP, internal procedures, and regulatory expectations

Requirements

  • 5–10 years of experience in a GMP-regulated environment (Pharma, Biotech, or Medical Devices)
  • Strong experience in QA operations and manufacturing support
  • Solid knowledge of deviation management, RCA, CAPA, change control
  • Familiar with regulatory inspections (FDA, EMA, Swissmedic, etc.)
  • Excellent communication, documentation, and decision-making skills
  • Bachelor's or Master's degree in Life Sciences, Chemistry, Biotechnology, or Engineering

Preferred Skills

  • Experience with sterile/aseptic operations, biologics, or solid dose manufacturing
  • Knowledge of Data Integrity (ALCOA+)
  • Familiarity with QMS platforms and digital solutions

What We Offer

  • Hybrid working model (on-site + remote flexibility)
  • Dynamic and collaborative environment
  • Opportunity to directly impact operational excellence and product quality
  • Career development within a fast-evolving organization

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