Device Reliability Testing Engineer driving reliability testing and qualification for graphene photonics products. Collaborating within engineering teams to ensure robust performance for production.
SI
Hybrid Manager, Clinical Quality Assurance
Posted 2 months ago
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
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Quality Assurance Technician involved in testing precision equipment and components. Collaborating in Continuous Improvement Processes and training service staff in Austria.
Manual QA Tester ensuring high quality and functionality of web applications for an international multi - asset broker. Collaborating in an Agile environment to maintain web application standards.
Quality Assurance Engineer responsible for developing QA strategies at desk:box. Building processes and standards to ensure software quality for digital office solutions.
QA/BA Consultant managing business analysis and quality assurance in fintech software. Collaborating with stakeholders and technical teams to deliver high - quality solutions in a hybrid role.
QA Manager ensuring quality for the Defense Metaverse at 21strategies GmbH. Focused on AI - driven simulations and extensive collaboration across development teams in a hybrid role.
Quality Engineer at STIHL responsible for maintaining quality standards for production processes and materials. Leading quality initiatives and audits to ensure compliance in manufacturing operations.
QA Analyst defining and evolving testing strategies while ensuring quality and reliability in financial solutions. Collaborating with development, product, and architecture teams in a regulated environment.
Training and Quality Assurance Specialist focused on empowering call center agents and ensuring standards. Collaborating with QA Departments to continuously enhance training modules and agent performance.
QA Engineer intern supporting testing activities across applications in a hybrid model at Verisk. Gain hands - on exposure to QA engineering practices and collaborate with experienced professionals in Kraków.