Manager, Quality Assurance – GMP
Summit Therapeutics, Inc.
full-time
Posted on:
Location Type: Hybrid
Location: Palo Alto • California, Florida, New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $122,000 - $143,000 per year
Job Level
Mid-LevelSenior
About the role
- 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
Requirements
- Bachelors 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) to execute quality processes
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GMP compliancerisk assessmentsroot cause analysiscorrective and preventive actionsquality metricsanalytical laboratory testingbiologics manufacturingquality assurancedocumentation preparationinspection readiness
Soft skills
organizational skillsattention to detailproblem-solving abilitieswork ethiccommunication skillscollaboration skillsability to handle multiple projectscross-functional teamwork