Summit Therapeutics, Inc. · 2 weeks ago
Senior Documentation Control Specialist
Palo Alto, CA
Full-time
Onsite
Senior Level
$97K/yr - $114K/yr
5+ years expSummit Therapeutics, Inc. is a biopharmaceutical oncology company focused on improving quality of life through innovative clinical studies. The Senior Documentation Control Specialist will support GxP operations, manage electronic quality management documentation, and ensure compliance with industry standards.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Support Quality team managing the electronic quality management documentation management system including uploading and archiving documents and handling associated requests
Delivers the ‘Service Owner’ role for the electronic Quality Management System to ensure the system is used by the wider organization and any error reporting is handled in an effective manner. Also ensures ongoing development and enhancement of the toolset to meet evolving business requirements
Checks / maintains the compliance and quality of the documents, in relation to Standard(s), Guidance and Summit’s procedures and expectations
Responds to documentation enquiries, giving appropriate access to information
Supports other functions in drafting, reviewing and approving documents / records using the QMS
Supports the ongoing maintenance and improvement of standard operating procedures and user guides
Reports on progress of documents ensuring that documents are reviewed and approved within the review cycle
Supports in any other tasks as deemed appropriate by the Line Manager
Support with QC checks for Regulatory and Safety team
Qualification
Required
Minimum of 5 years of experience in a biotech or pharma industry
Bachelor's degree in science/life science related field and/or pharmaceutical sciences
Must have excellent verbal and written communication skills
Must be highly organized with a strong attention to detail
Intermediate to advanced skills in MS Office Suite (Outlook, Excel, Word, PowerPoint)
Ability to work with minimal guidance; Proactive, motivated self-starter
Understands pertinent regulations for the industry, for example, GLP, GCP, and 21 CFR Part 210, 211, and 820, ICH Guidelines, etc
Minimum of two years in Quality Assurance in the Pharmaceutical/Biotechnology industry
Experience in maintaining GXP training records, materials, or courses
Benefits
Bonus
Stock
Benefits
Other applicable variable compensation
Company
Summit Therapeutics, Inc.
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.
201-500 employees
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 CompanyTotal Funding
$1.79BKey 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
Manmeet Soni
Chief Operating Officer and Board Member
Recent News
2025-12-09
2025-12-05
Company data provided by crunchbase