CI&T seeks a Senior Quality Assurance professional to develop test automation for financial clients. Engage in full software development lifecycle within a collaborative environment.
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
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