Director, GMP Quality Assurance
$213,000–$240,000 year
Hybrid · Menlo Park, California, United States or Waltham, Massachusetts, United States
Job Summary
Director of GMP Quality Assurance overseeing quality oversight for Oruka’s clinical development programs and manufacturing, ensuring compliance with phase-appropriate regulatory requirements and industry best practices. Lead QA activities across GMP documentation, deviations, CAPA, change controls, lot disposition, QMS development, labeling controls, and regulatory support. Collaborate with external GMP suppliers/CDMOs, support inspections and regulatory submissions, and drive continuous improvement with KPI tracking; travel ~15–20% to GMP suppliers and Oruka offices. Hybrid in-office presence required in Waltham, MA or Menlo Park, CA with remote options for non-local candidates.
Required Qualifications
- Bachelor’s degree in a scientific field
- Minimum 10 years of experience in GMP Quality or Manufacturing in biotechnology/pharmaceutical setting; experience in biologics required
- In-depth knowledge of cGMP, FDA/EMA regulations, and applicable guidelines (ICH, WHO)
- Experience supporting early phase clinical through commercial manufacturing, including use of contract manufacturers
- Strong analytical, investigative, and problem-solving skills; ability to design creative solutions
- Excellent interpersonal and communication skills; team-oriented; ability to mentor and develop junior staff
- Ability to work in a fast-paced, ever-changing environment; prioritize and manage multiple tasks
- Ability to travel domestically and internationally
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