Sr. Manager, Clinical Quality Assurance

The role

This person will provide GCP, GLP, and GPV compliance advice to internal clinical study teams. They will manage audits, support CAPAs, and ensure quality management for clinical and pre-clinical programs.

What you will do

• Partner with R&D teams to provide Quality support to Clinical and pre-clinical programs
• Manage audits including Clinical Sites and Vendor Qualification
• Ensure end-to-end quality management through proactive compliance
• Liaise with Global Audits and Compliance function to provide lessons learned and support corrective actions
• Support CRO-relevant meetings to provide quality overview and training
• Support development, execution, coordination, and review of CAPAs
• Support formal investigations of issues and escalate critical incidents
• Identify areas of continuous process improvement
• Provide QA support in interactions with internal and external contacts and Health Authorities
• Assist in preparing program teams for FDA, EU, and key HA inspections

Required qualifications

• Bachelor's Degree in Life Sciences, Pharmacy or Nursing
• 5 or More Years Quality Assurance experience and or Clinical Operations involvement in regulated activities or equivalent experience
• 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
• Ability to effectively multi-task and manage time-sensitive and highly confidential documents
• Ability to communicate complex ideas in an easily understandable way
• Ability to prioritize conflicting demands
• Ability to work in a fast-paced, demanding and collaborative environment
• Ability to travel up to 20%

Nice to have

• Master's Degree or other advanced degree
• 5 or More Years broad understanding of global expectations of Health Authorities in the management of clinical trials
• 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
• Proficiency in Mandarin Chinese (spoken and written) is highly desirable
• Proficient user of standard MS Office suite (e.g., Word, Excel)
• Experience using electronic document management systems, and document review tools
• Fluent in Madrin highly preferred

About the company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. The company has multiple global Phase 3 clinical studies in the field of oncology.