Manager, Clinical Quality Assurance (GCP) jobs in United States
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Summit Therapeutics, Inc. · 1 day ago

Manager, Clinical Quality Assurance (GCP)

positionMenlo Park, CA
timeFull-time
remoteHybrid
seniorityMid, Senior Level
money$139K/yr - $163K/yr
date5+ years exp

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing serious unmet medical needs. The Manager, Clinical QA will collaborate with various departments to ensure compliance with GCP/GLP/GPV standards and provide quality support for clinical studies.

BiotechnologyHealth CareMedical DeviceTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Partnering and collaborating with key stakeholders (R&D teams) to ensure that appropriate Quality support is provided to Summit Clinical and pre-clinical programs
Ensuring end-to-end quality management through proactive compliance based on Clinical Development Plan (CDP)
Liaising with the Global Audits and Compliance function to provide lessons learned from audits and inspections to program teams and support implementation of corrective actions
Supporting CRO-relevant meetings, when necessary, to provide quality overview/ training to relevant stakeholders
Providing support during the development and execution of Corrective and Preventive Actions (CAPAs). Coordinating and reviewing CAPAs to ensure adequate CAPAs are defined, implemented, and closed
Support formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidents are not resolved in due course
Identifying areas of continuous process improvement and engaging QA and key stakeholders as necessary
QA support in interactions with internal and external contacts and Health Authorities (HA), as appropriate. In collaboration with the Global QA team, ensure inspection management by assisting in preparing program teams for FDA, EU, and key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspections
Support in providing interpretation of regulations and company process standards, guidelines, policies, and procedures to personnel for assigned programs or for continuous improvement projects
Supporting or leading development and driving the implementation of study/program-specific quality plans to ensure proactive management of quality
Supporting rectifying any necessary vendor-relevant issues identified for the assigned program
Ensuring that protocols for assigned programs can be operationalized and address potential risks with key stakeholders
Perform internal audits as applicable
All other duties as assigned

Qualification

Quality Assurance experienceGCP/GLP regulationsClinical Operations involvementLife Sciences degreeMS Office proficiencyAttention to detailClear communicationOrganizational skillsCritical thinkingProblem solving

Required

Bachelor's Degree in Life Sciences, Pharmacy, or Nursing
Minimum of 5+ or more years Quality Assurance experience and or Clinical Operations involvement in regulated activities or equivalent experience
Ability to travel up to 20%
Attention to detail, accuracy and confidentiality
Clear and concise oral and written communication skills
Excellent organizational skills
Critical thinking, problem solving, ability to work independently
Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
Communicate effectively and articulate complex ideas in an easily understandable way
Prioritize conflicting demands
Work in a fast-paced, demanding and collaborative environment

Preferred

Master's Degree or other advanced degree
Broad understanding of global expectations of Health Authorities in the management of clinical trials
Thorough understanding of international GCP/GLP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidance's, and current industry practice
Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools
Strong computer and database skills

Benefits

Bonus
Stock
Benefits
Other applicable variable compensation

Company

Summit Therapeutics, Inc.

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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

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Manmeet Soni
Chief Operating Officer and Board Member
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