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, Menlo Park, United States

About the role

• Manager of Clinical Quality Assurance focusing on quality support for clinical studies in oncology. Collaborating with cross-functional teams to ensure compliance and effective quality management.

Responsibilities

• Collaborate closely 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
• Ensure tactical support is provided to assignments and wherever necessary, taking the lead in ensuring project related procedural documents, comply to relevant GxPs and regulatory requirements and guidelines
• Partnering and collaborating with key stakeholders (R&D teams) to ensure that appropriate Quality support is provided to Summit Clinical and pre-clinical programs
• Ensuring end-to-end quality management through proactive compliance based on Clinical Development Plan (CDP)
• Liaising with the Global Audits and Compliance function to provide lessons learned from audits and inspections to program teams and support implementation of corrective actions
• Supporting CRO-relevant meetings, when necessary, to provide quality overview/ training to relevant stakeholders
• Providing support during the development and execution of Corrective and Preventive Actions (CAPAs)
• Coordinating and reviewing CAPAs to ensure adequate CAPAs are defined, implemented, and closed
• Support formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidents are not resolved in due course
• Identifying areas of continuous process improvement and engaging QA and key stakeholders as necessary
• QA support in interactions with internal and external contacts and Health Authorities (HA), as appropriate
• Ensure inspection management by assisting in preparing program teams for FDA, EU, and key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspections
• Support in providing interpretation of regulations and company process standards, guidelines, policies, and procedures to personnel for assigned programs or for continuous improvement projects
• Supporting or leading development and driving the implementation of study/program-specific quality plans to ensure proactive management of quality
• Supporting rectifying any necessary vendor-relevant issues identified for the assigned program
• Ensuring that protocols for assigned programs can be operationalized and address potential risks with key stakeholders
• Perform internal audits as applicable
• All other duties as assigned

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