Senior QA Manager, GCP Clinical Trials | Flexible Hours

Tranquil Clinical Research and Consulting Services; Webster (TX); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Performance-based compensation

Flexible working hours

International collaboration

Job summary

Tranquil Clinical Research and Consulting Services seeks an experienced Senior QA Manager to lead QA in a GCP-regulated clinical trials environment. You will drive audits, CAPA, risk management, and SOP/training programs while collaborating with global stakeholders.

Join a role that combines hands-on quality expertise with strategic oversight across Clinical Operations, Regulatory Affairs, and Data Management.

Qualifications

• University degree in Life Sciences, Pharmacy, Medicine, or a related field.
• Several years of professional experience in Quality Assurance within clinical trials, ideally within a GCP regulated enviroment.

Responsibilities

• Plan, conduct, report and track audits (process, vendor qualification, system, study-specific).
• Ensure compliance with GCP, ICH, FDA regulations and company standards.
• Own and manage Deviation and CAPA processes with root cause analysis and effectiveness checks.
• Drive risk management activities including risk assessments and mitigation.
• Lead change management related to quality systems and clinical operations.
• Create, review, approve, and lifecycle manage QA SOPs.
• Prepare role-based training materials and conduct training in GCP/FDA setting.
• Prepare quality metrics, management reports, and audit summaries for upper management.
• Act as QA contact for regulatory inspections and sponsor audits.
• Collaborate with Clinical Ops, Project Management, Regulatory Affairs, Data Management, Medical Writing and externals.
• Support continuous improvement within the QMS.
• Review validation docs for computerized systems including eQMS.

Skills

Audit planning

Inspection readiness

Risk management

Change management

SOP and training management

Stakeholder communication

Travel willingness

Education

University degree in Life Sciences/Pharmacy/Medicine or related field

Tools

eQMS

Job description

Tranquil Clinical Research and Consulting Services seeks an experienced Senior QA Manager to lead QA in a GCP-regulated clinical trials environment. You will drive audits, CAPA, risk management, and SOP/training programs while collaborating with global stakeholders.

Join a role that combines hands-on quality expertise with strategic oversight across Clinical Operations, Regulatory Affairs, and Data Management.