Hybrid Manager, Clinical Quality Assurance

at Summit Therapeutics, Inc.

• Job title: Manager, Clinical Quality Assurance
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $139,000 - $163,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform
• Location requirements: Hybrid, Princeton, United States

About the role

• Manager, Clinical QA providing compliance-related advice in oncology at Summit Therapeutics. Collaborating with key stakeholders to ensure end-to-end quality management of clinical studies.

Responsibilities

• Collaborate closely with Regulatory Affairs, QA, R&D and other cross-functional teams within the Company to provide GCP/GLP/GPV and compliance-related advice to internal clinical study teams
• Ensure end-to-end quality management through proactive compliance based on Clinical Development Plan (CDP)
• Liaise with the Global Audits and Compliance function to provide lessons learned from audits and inspections to program teams and support implementation of corrective actions
• Support formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidents are not resolved in due course
• Identify areas of continuous process improvement and engage QA and key stakeholders as necessary
• Manage inspection preparation and follow-up post inspections
• Support development and implementation of study/program-specific quality plans to ensure proactive management of quality
• Perform internal audits as applicable

Requirements

• Bachelor's Degree in Life Sciences, Pharmacy, or Nursing required
• Master's Degree or other advanced degree preferred
• Minimum of 5+ or more years Quality Assurance experience and or Clinical Operations involvement in regulated activities or equivalent experience required
• Broad understanding of global expectations of Health Authorities in the management of clinical trials preferred
• Thorough understanding of international GCP/GLP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidances, and current industry practice preferred
• 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