Senior Manager, Clinical Quality Assurance

🕒 September 9

🇺🇸 United States – Remote

💵 $158k - $185k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 17%

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2003

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of innovative medicinal therapies aimed at improving quality of life for oncology patients. The company is particularly committed to addressing serious unmet medical needs through its lead investigational therapy, ivonescimab, a novel bispecific antibody designed to target both PD-1 and VEGF. Summit’s initiatives include ongoing Phase III clinical trials to evaluate ivonescimab's effectiveness in treating non-small cell lung cancer, highlighting their dedication to patient-centered care and technological advancement in the field of oncology.

📋 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 and lead, where necessary, the development and compliance of project-related procedural documents with relevant GxPs and regulatory requirements • Partner with R&D stakeholders to provide Quality support for clinical and pre-clinical programs • Manage clinical site and vendor qualification audits • Ensure end-to-end quality management through proactive compliance based on the Clinical Development Plan • Liaise with Global Audits and Compliance to share audit and inspection lessons learned and support corrective action implementation • Support CRO meetings by providing quality overview and training • Support development and execution of Corrective and Preventive Actions (CAPAs), including coordinating, reviewing, implementing, and closing CAPAs • Support formal investigations and escalate critical unresolved incidents to line management • Identify continuous process improvement opportunities • Support interactions with internal and external contacts and Health Authorities • Assist program teams preparing for FDA, EU, and key Health Authority inspections and provide post-inspection follow-up • Interpret regulations, company standards, guidelines, policies, and procedures • Support or lead study/program-specific quality plans and implementation • Address vendor-related issues • Ensure assigned-program protocols can be operationalized and address potential risks • Perform internal audits for the Quality Systems internal audit program

🎯 Requirements

• Bachelor's Degree in Life Sciences, Pharmacy or Nursing required • 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) 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, and ability to work independently • Ability to effectively multi-task and manage time-sensitive and highly confidential documents • Ability to communicate effectively and articulate complex ideas in an easily understandable way • Ability to prioritize conflicting demands • Ability to work in a fast-paced, demanding and collaborative environment • Fluent in Mandarin highly preferred yet not required

🏖️ Benefits

• Bonus • Stock • Benefits and/or other applicable variable compensation • Ability to work remotely

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