Manager, Quality Assurance (GMP) jobs in United States
cer-icon
Apply on Employer Site
company-logo

Summit Therapeutics, Inc. · 6 hours ago

Manager, Quality Assurance (GMP)

positionPalo Alto, CA
timeFull-time
remoteOnsite
senioritySenior Level
money$122K/yr - $143K/yr
date5+ years exp

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. The Manager, Quality Assurance will support GMP compliance related to drug manufacturing processes, contributing to quality assurance activities and ensuring compliance with applicable regulations and industry standards.

BiotechnologyHealth CareMedical DeviceTherapeutics
check
H1B Sponsor Likelynote

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

Qualification

GMP complianceQuality assurance systemsBiologics experienceE-QMS systemsRegulatory inspectionsFluency in MandarinOrganizational skillsAttention to detailProblem-solvingCommunication skills

Required

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
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

Preferred

Experience supporting audits and regulatory inspections is a plus
Fluency in Mandarin is a plus

Benefits

Bonus
Stock
Benefits
Other applicable variable compensation

Company

Summit Therapeutics, Inc.

twittertwittertwitter
company-logo
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.
dateFounded in 2003
location
Abingdon, Oxfordshire, GBR
people-size201-500 employees
web-link
https://www.smmttx.com/

H1B Sponsorship

Summit Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)

Funding

Current Stage
Public Company
Total Funding
$1.79B
Key Investors
CARB-XEurofarmaBiomedical Advanced Research and Development Authority (BARDA)
2025-10-21Post Ipo Equity· $500M
2024-09-11Post Ipo Equity· $235M
2024-06-03Post Ipo Equity· $200M

Leadership Team

leader-logo
Manmeet Soni
Chief Operating Officer and Board Member
linkedin

Recent News

Benzinga.com
Wall Street's Most Accurate Analysts Give Their Take On 3 Health Care Stocks Delivering High-Dividend Yields
2026-01-16
BioSpace
Summit Therapeutics Announces Clinical Trial Collaboration with GSK to Evaluate Ivonescimab in Combination with GSK’s B7-H3 Antibody Drug Conjugate (ADC)
2026-01-13
The Motley Fool
2 Biotech Stocks That Could Soar This Year
2026-01-13
Company data provided by crunchbase