🛠 Tech Stack

💼 About This Role

You'll lead validation and computer system assurance programs for a biotech company's GMP manufacturing and lab systems. You'll establish risk-based frameworks to ensure compliance with FDA/EU regulations and data integrity. This role offers the opportunity to modernize validation practices using CSA and digital approaches.

🎯 What You'll Do

• Develop and implement Quality Engineering and CSA strategies and governance.
• Oversee validation lifecycle documentation including VMPs, URS, risk assessments, and protocols.
• Ensure computerized systems comply with data integrity (ALCOA++) and GAMP 5.
• Lead quality oversight for change control, deviations, CAPAs, and risk assessments.
• Manage and develop a high-performing Quality Engineering and CSA team.

📋 Requirements

• Bachelor's degree in a scientific discipline (advanced degree preferred).
• 10+ years of GMP and Quality experience in pharmaceutical or biotechnology.
• 5+ years of qualification/validation/CSA experience in QA or technical capacity.
• Experience with FDA and EU regulatory inspections.

✨ Nice to Have

• Preference for advanced degree (MS/PhD).
• Experience with MES, LIMS, QMS, and ERP systems.
• Certification in validation or quality (e.g., ASQ CQE).

🎁 Benefits & Perks

• 🏥 Health, dental, and vision insurance
• 💰 401(k) with company match
• 🏖️ Paid time off and holidays
• 📚 Professional development opportunities

🚩 Heads Up

• Requires 10+ years experience but no explicit senior title in name.
• Broad scope covering both engineering and quality assurance may stretch resources.