Senior Quality Assurance Manager in Webster, Texas at Tranquil Clinical and Research Consulting Services LLC

Role Overview

We are seeking an experienced and motivated Senior Quality Assurance (QA) Manager – Clinical Trials to further develop our QA function within the clinical research environment. This role combines hands-on quality expertise with close collaboration with cross-functional and international stakeholders.

Key Responsibilities

· Plan, conduct, report and track internal and external audits (e.g. process audits, vendor qualification audits, system and study specific audits and inspections)

· Ensure compliance with GCP, ICH guidelines, FDA regulations, applicable regulatory requirements, and company standards

· Own and manage Deviation and CAPA processes, including root cause analysis, tracking, and effectiveness checks

· Drive risk management activities, including risk assessments and mitigation strategies

· Lead and support change management processes related to quality systems and clinical operations

· Responsible for the creation, review, approval, and lifecycle management of QA SOPs

· Preparation of role-based training materials and conduct of training courses in the GCP/FDA regulated setting

· Prepare quality metrics, management reports, and audit summaries for upper management

· Act as a key QA contact for regulatory inspections and sponsor audits

· Collaborate closely with Clinical Operations, Project Management, Regulatory Affairs, Data Management, Medical Writing and external partners

· Support continuous improvement initiatives within the Quality Management System (QMS)

· Review and approve validation documentation (e.g. validation plans, risk assessments, test scripts, validation reports) for computerized systems, including eQMS and other GxP-relevant systems

Qualifications & Experience

· University degree in Life Sciences, Pharmacy, Medicine, or a related field

· Several years of professional experience in Quality Assurance within clinical trials

· Senior QA professional

· Strong knowledge of GCP, ICH and international regulatory requirements (e.g. FDA regulations)

· Demonstrated experience in:

• Audit planning, performance, and reporting
• Deviation and CAPA management
• Risk management
• Change management
• SOP and training management

· Willingness to travel nationally and internationally, particularly within/to Germany, within Europe and the USA

· Strong organizational, analytical, and problem-solving skills

· Confident communication style and ability to work with stakeholders at all levels

What We Offer

· A responsible senior role in an international clinical research environment

· High level of autonomy and the opportunity to actively shape QA processes

· Collaboration with global teams and exposure to international projects

· A thorough and practice-oriented onboarding

· Performance-based compensation and flexible working hours

· A company culture strongly characterized by trust and collegiality

· An exciting workplace with opportunities for professional and personal development, for example development into a team lead function