Director, Clinical Quality Operations

at  Sequel Medical Technology

ABOUT SEQUEL

Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.

• Clinical Trial Management: Oversee the planning, execution, and monitoring of clinical trials to ensure compliance with protocols, regulatory requirements, and industry standards.
• Quality Assurance: Develop and implement quality assurance programs and processes to ensure the highest standards of clinical quality throughout the product lifecycle.
• Regulatory Compliance: Ensure compliance with all relevant regulatory requirements, including FDA and EU regulations, ISO standards, and Good Clinical Practice (GCP) guidelines.
• Risk Management: Identify potential risks to clinical quality and develop strategies to mitigate risks effectively. Conduct risk assessments and implement controls to ensure the safety and integrity of clinical trials.
• Vendor Management: Manage relationships with external vendors, including contract research organizations (CROs) and clinical trial sites, to ensure quality and compliance with contractual agreements.
• Data Management: Oversee data collection, analysis, and reporting for clinical trials. Ensure the accuracy, integrity, and confidentiality of clinical trial data.
• Audit Support: Facilitate and oversee the responses to audit and inspection observations. Maintain regulatory inspection knowledge as it relates to GCP inspections by regulatory agencies worldwide. Develop, update and maintain GCP inspection procedures and guidelines.
• CAPA Management Support: Ensure all actions related to audits and inspections are implemented in a timely manner. Track all inspection CAPA
• Training and Education: Provide training and support to clinical operations staff and other stakeholders to promote awareness and understanding of clinical quality requirements and best practices.
• Continuous Improvement: Drive continuous improvement initiatives to enhance the efficiency and effectiveness of clinical quality operations. Identify opportunities for process optimization and innovation. Recognize and respond to new and emerging risks through the use of technology.
• Cross-Functional Collaboration: Collaborate with cross-functional teams, including research and development, regulatory affairs, and quality assurance, to ensure alignment and integration of clinical quality activities with overall business objectives