Senior Manager, Clinical Quality Assurance

🔥 20 hours ago

🇺🇸 United States – Remote

💵 $158k - $185k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2003

🏥 Healthcare

💼 Consulting

📣 Marketing

🔥 Funding within the last year

💰 $500M Post-IPO Equity - Summit Therapeutics on 2025-10

Healthcare • Consulting • Marketing

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of novel medicinal therapies to improve quality and duration of life for patients with serious unmet medical needs. The company is advancing ivonescimab (SMT112), a novel bispecific antibody targeting PD-1 and VEGF, through multiple Phase 3 clinical trials for non-small cell lung cancer and other solid tumors under license from Akeso. Summit emphasizes clinical development, regulatory filing strategies, and potential commercialization in its licensed territories while promoting patient- and caregiver-friendly treatment options.

📋 Description

• Collaborate with Regulatory Affairs, QA, R&D and other cross-functional teams to provide GCP/GLP/GPV and compliance-related advice to internal clinical study teams • Provide tactical support for assignments and lead, where necessary, efforts ensuring project-related procedural documents comply with relevant GxPs and regulatory requirements and guidelines • Partner with R&D stakeholders to provide Quality support to clinical and pre-clinical programs • Manage clinical site audits and vendor qualification audits • Ensure end-to-end quality management through proactive compliance based on the Clinical Development Plan (CDP) • Liaise with Global Audits and Compliance to share audit and inspection lessons learned and support corrective-action implementation • Support CRO-relevant meetings by providing quality overview/training when necessary • Support development and execution of Corrective and Preventive Actions (CAPAs); coordinate and review CAPAs through definition, implementation, and closure • Support formal investigations and escalate critical unresolved incidents to line management • Identify continuous process-improvement opportunities and engage QA and stakeholders • Support interactions with internal/external contacts and Health Authorities • Assist program teams in preparation for FDA, EU, and key Health Authority inspections; provide inspection-management and post-inspection follow-up support • Interpret regulations, company process standards, guidelines, policies, and procedures for assigned programs and continuous-improvement projects • Support or lead development and implementation of study/program-specific quality plans • Rectify vendor-related issues for assigned programs • Ensure assigned-program protocols can be operationalized and address potential risks with stakeholders • Perform internal audits supporting the Quality Systems internal audit program

🎯 Requirements

• Bachelor's Degree in Life Sciences, Pharmacy or Nursing required • Master's Degree or other advanced degree preferred • 5 or More Years Quality Assurance experience and/or Clinical Operations involvement in regulated activities or equivalent experience required • 5 or More Years broad understanding of global expectations of Health Authorities in the management of clinical trials preferred • 5 or More Years thorough and extensive knowledge of international GCP/GLP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidance’s, and current industry practice preferred • Proficiency in Mandarin Chinese (spoken and written) is highly desirable • Ability to travel up to 20% • Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable • Strong computer and database skills • 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 • Fluent in Mandarin highly preferred yet not required

🏖️ Benefits

• Potential bonus • Stock • Benefits and/or other applicable variable compensation • Equal opportunity employer committed to a diverse environment