Manager, Quality Assurance – GMP
Summit Therapeutics, Inc.
full-time
Posted on:
Location Type: Hybrid
Location: Miami • Florida • 🇺🇸 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
- 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) 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 quality systemsrisk assessmentsroot cause analysiscorrective and preventive actions (CAPAs)quality metricsanalytical laboratory testingbiologics manufacturinge-QMS systemsdocumentation preparationinternal audits
Soft skills
organizational skillsattention to detailproblem-solving abilitieswork ethiccommunication skillscollaboration skillsability to handle multiple projectscross-functional teamwork