Senior QA Manager - Clinical Trials, Flexible Hours

Tranquil Clinical and Research Consulting Services LLC; Webster (TX); On-site; USD 95,000 - 115,000; Full time

Benefits offered by this job

Autonomy in QA processes

International collaboration

Flexible working hours

Job summary

Tranquil Clinical and Research Consulting Services LLC, based in Webster, TX, seeks a Senior Quality Assurance Manager (Clinical Trials) to advance QA within a global clinical research setting. The role blends hands-on QA with cross-functional collaboration across international stakeholders.

The candidate will drive audits, CAPA, risk management and training in a GCP/FDA regulated environment, ensuring lifecycle QA from SOPs to evidence-based improvements.

Qualifications

• University degree in Life Sciences, Pharmacy, Medicine or related field.
• Several years of professional QA experience in clinical trials.
• Strong knowledge of GCP, ICH and FDA regulatory requirements.

Responsibilities

• Plan, conduct, report and track internal and external audits (process, vendor qualification, system, study audits).
• Ensure compliance with GCP, ICH, FDA and regulatory requirements.
• Own and manage Deviation and CAPA processes with root cause analysis and effectiveness checks.
• Drive risk management activities including assessments and mitigation strategies.
• Lead change management related to QA systems and clinical operations.
• Prepare QA SOPs, their review and lifecycle management.

Skills

Quality Assurance

Regulatory knowledge

Audit planning

Cross-functional collaboration

Travel availability

Education

University degree in Life Sciences/Pharmacy/Medicine

Job description

Tranquil Clinical and Research Consulting Services LLC, based in Webster, TX, seeks a Senior Quality Assurance Manager (Clinical Trials) to advance QA within a global clinical research setting. The role blends hands-on QA with cross-functional collaboration across international stakeholders.

The candidate will drive audits, CAPA, risk management and training in a GCP/FDA regulated environment, ensuring lifecycle QA from SOPs to evidence-based improvements.