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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