22h ago

Sr. Director, Global Quality Control

Cambridge, MA

$245k-$335k / year

full-timedirector Hybridbiotech

💼 About This Role

You'll lead the global QC function for a biopharmaceutical company developing life-changing therapies. You'll establish a phase-appropriate, inspection-ready strategy for a fully outsourced network. This role offers the opportunity to shape scalable QC systems for a growing pipeline.

🎯 What You'll Do

  • Lead global QC function across fully outsourced model.
  • Define and execute global QC strategy and stability programs.
  • Oversee method qualification, validation, and transfer at external labs.
  • Provide QC leadership for investigations and regulatory compliance.

📋 Requirements

  • 15+ years of progressive QC experience in biotech/pharma.
  • 7+ years in leadership roles with outsourced operating models.
  • Deep technical expertise in analytical methods for biologics.
  • Strong knowledge of cGMP, ICH, and global regulatory requirements.

✨ Nice to Have

  • Advanced degree (MS or PhD) preferred.
  • Experience with post-approval specification management.
  • Proven ability to lead through influence in matrixed organizations.

🎁 Benefits & Perks

  • 🏥 Health Insurance
  • 💰 Competitive Salary
  • 🏖️ PTO
  • 📈 Equity
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