Principal Quality Leader

Job Summary

Providing technical expertise and leadership within a Product Quality Team, the full-time remote Principal Product Quality Leader will engage with various departments to support product filings, program improvements, and investigations related to product manufacturing and quality assurance.

Key responsibilities

• Provide cross-functional quality leadership and support program deliverables for late-phase and commercial programs
• Support science and risk-based evaluation of complex process and product quality data
• Author and review GMP and regulatory documents, managing product quality-related activities

Required qualifications

• Doctorate degree and 2 years of relevant experience, or equivalent combinations of education and experience
• B.S. or advanced degree in chemistry, biochemistry, biology, or related field preferred
• 6+ years working in a regulated environment with biologic products
• Experience with authoring or reviewing regulatory documentation
• Proficiency in knowledge of cGMP and international regulatory expectations