Senior Quality Assurance Manager

Tranquil Clinical and Research Consulting Services • Webster, TX

3d

About The Position

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.

Requirements

• 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
• Demonstrated experience in: Deviation and CAPA management
• Demonstrated experience in: Risk management
• Demonstrated experience in: Change management
• Demonstrated experience in: 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

Nice To Haves

• development into a team lead function

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

Benefits

• Performance-based compensation
• flexible working hours

What This Job Offers

• Job Type: Full-time
• Career Level: Senior