Manager, Clinical Quality Assurance (GCP)

Summit Therapeutics Plc•Menlo Park, CA

14d•$139,000 - $163,000•Hybrid

About The Position

The Manager, Clinical QA will 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. This will be accomplished through ensuring tactical support is provided to assignments and wherever necessary, taking the lead in ensuring project related procedural documents, comply to relevant GxP's and regulatory requirements and guidelines.

Requirements

Bachelor's Degree in Life Sciences, Pharmacy, or Nursing required
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 guidance's, 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

Nice To Haves

Master's Degree or other advanced degree preferred

Responsibilities

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. In collaboration with the Global QA team, 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