Hybrid Manager, Quality Assurance – GMP

at Summit Therapeutics, Inc.

• Job title: Manager, Quality Assurance – GMP
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $122,000 - $143,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Princeton, United States

About the role

• Manager, Quality Assurance overseeing GMP compliance and quality systems in biopharmaceutical manufacturing. Collaborating for inspection readiness and batch approval processes while ensuring regulatory compliance.

Responsibilities

• Support the development, implementation, and maintenance of GMP quality systems, including policies, procedures, and risk assessments in alignment with global health authority regulations (FDA, EMA, ICH, etc.)
• Assist in ensuring GMP compliance at Contract Manufacturing Organizations (CMOs) by providing sponsor oversight and supporting clinical and commercial manufacturing activities
• Participate in inspection readiness activities, including documentation preparation and coordination for internal audits and regulatory inspections
• Assist with investigations, root cause analysis, risk assessments, and corrective and preventive actions (CAPAs) to ensure timely resolution of quality-related issues
• Support internal QA batch review and release processes to ensure compliance with applicable regulations
• Review and help maintain controlled documents, including Standard Operating Procedures (SOPs), to align with regulatory requirements and industry best practices
• Collaborate with cross-functional teams to achieve quality and compliance objectives
• Assist in tracking and maintaining quality metrics and performance indicators
• Perform other duties as assigned to support Quality Assurance initiatives
• All other duties as assigned

Requirements

• Bachelor's degree in chemistry, biochemistry, life sciences, biotechnology, or a related field
• Minimum of 5+ years of relevant experience in the pharmaceutical or biotechnology industry, with a focus on GMP manufacturing
• Experience with biologics essential; familiarity with analytical laboratory testing is a plus
• Experience working with e-QMS systems (e.g., MasterControl, TrackWise)
• Understanding of GMP requirements for clinical and commercial biologics manufacturing
• Experience supporting audits and regulatory inspections is a plus
• Strong organizational skills with the ability to handle multiple projects in a fast-paced environment
• Excellent attention to detail, problem-solving abilities, and a strong sense of work ethic
• Effective communication and collaboration skills, with the ability to work cross-functionally
• Fluency in Mandarin is a plus.

Benefits

• Bonuses
• Stock options
• Health insurance
• Retirement plans
• Paid time off