Senior Manager, Clinical Quality Assurance
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Job Description
Clinical Quality Assurance Manager supporting GCP compliance, audits, CAPAs, and inspections. Helping Summit Therapeutics advance global oncology clinical studies and investigational therapies.
Responsibilities:
- 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
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