Overview
Senior Quality Assurance Manager Jobs in Jackson, MS at ImmunoTek Bio Centers, LLC
Job Summary
The role focuses on ensuring the success of clinical trials by establishing and maintaining robust processes, troubleshooting challenges and managing quality-related data. The individual will collaborate with cross-functional teams to identify gaps in processes, implement improvements, and ensure compliance with relevant quality legislation. Key responsibilities include conducting audits, monitoring trial progress, maintaining databases, preparing reports, and facilitating continuous improvement initiatives. The position requires strong analytical skills, attention to detail, and effective communication to educate teams about regulatory requirements.
Responsibilities
1. Ensure all processes contributing to the success of a clinical trial are in place:
– Collaborate with cross-functional teams to identify and establish necessary processes.
– Conduct regular reviews and audits to ensure compliance with established processes.
– Coordinate with stakeholders to address any gaps or inconsistencies in processes.
– Implement corrective actions when necessary to enhance trial success.
2. Troubleshoot clinical trials and activities:
– Identify and resolve technical issues or challenges encountered during clinical trials.
– Collaborate with investigators, sponsors, and vendors to troubleshoot problems and find solutions.
– Monitor trial progress and identify potential risks or deviations from the plan.
– Develop and implement contingency plans to mitigate potential trial disruptions.
3. Manage and maintain databases for the quality system:
– Develop and maintain databases to track quality-related data, metrics, and trends.
– Ensure the accuracy and integrity of data collected within the quality system.
– Generate reports and analyze data to identify areas for improvement.
– Collaborate with team members to identify and implement process improvements to enhance data quality.
4. Prepare and assist in preparing annual reports and quality trending reports:
– Collect and analyze data to create comprehensive reports on quality performance.
– Identify trends, issues, and opportunities for improvement within the quality system.
– Collaborate with stakeholders to develop and implement corrective actions to address identified concerns.
– Prepare quality reports for senior management and regulatory agencies.
– Collaborate with team members to develop and implement strategies to improve quality levels.
– Identify and escalate any critical compliance risks or issues to senior management.
6. Improvement programs:
-Implement continuous improvement initiatives within the quality system.
– Identify areas for improvement and develop strategies to enhance quality performance.
– Collaborate with cross-functional teams to implement and monitor improvement projects.
– Maintain documentation related to quality events and incidents, ensuring compliance with regulatory requirements.
8. Stay updated with all related quality legislation and compliance issues:
– Stay informed about changes in quality regulations and compliance standards.
– Implement appropriate measures to ensure compliance with relevant legislation.
– Collaborate with legal and compliance teams to ensure adherence to legal requirements.
– Provide guidance to team members on quality-related compliance issues.
9. Compile materials for submission to regulatory agencies
10. Communicate regulatory requirements to the operations team:
– Educate and inform the operations team about regulatory requirements relevant to clinical trials.
11. Interpret guidance documents, international standards, or consensus standards
Requirements
Bachelor/ master’s degree in clinical research, Quality Assurance, or a related field.
Minimum of 2-3 years of experience in clinical trial management, quality assurance and or a related field.
Experience with clinical trial processes and regulations.
Strong analytical and problem-solving skills.
Proficient in data management and analysis tools.
Excellent communication and interpersonal skills to collaborate with cross-functional teams.
Knowledge of regulatory requirements and compliance standards in clinical trials.
Ability to develop and implement process improvements effectively.
Ability to stay updated on quality legislation and compliance issues.
Strong organizational skills and attention to detail.
Capacity to handle multiple tasks and prioritize effectively in a fast-paced environment.
Job Type: Full-time
Schedule:
Monday to Friday
Experience:
Quality assurance: 2 years (Required)
Clinical trials: 2 years (Required)
Analysis skills: 2 years (Required)
Ability to Relocate:
Houston, TX 77074: Relocate before starting work (Required)
Work Location: In person
Title: Senior Quality Assurance Manager
Company: ImmunoTek Bio Centers, LLC
Location: Jackson, MS
