Quality Management Systems Specialist III

TITLE: Quality Management Systems Specialist III

REPORTS TO: Supervisor, Quality Management Systems

Velocity Bioworks is a U.S.

-based biopharma CDMO headquartered in San Antonio, Texas supporting funded programs as they move from development into manufacturing for clinical trials. We collaborate with sponsors who are past exploration and are ready to apply discipline, structure, and technical rigor to development, analytics, and manufacturing.

Velocity is built to accelerate speed to clinic through aligned execution. Our work focuses on translating defined program goals into scalable manufacturing processes and robust analytical strategies. These activities are designed to support near-term clinical timelines while meeting quality requirements. We operate where quality and execution directly influence clinical and business progress.

The Quality Management Systems Specialist III is instrumental in implementing and maintaining an organizational-wide Quality Management System. This position works closely with the Supervisor of Quality Management Systems to develop, implement and maintain policies, procedures and systems to ensure compliance with internal procedures and current Good Manufacturing Practices (CGMP), and applicable regulatory standards.

Additional responsibilities include the identification of deficiencies or gaps, developing solutions to ensure adequate and robust quality processes using root cause analysis, and optimizing workflows to comply with existing and new regulatory requirements. The ideal candidate must exhibit strong attention to detail, effective time-management skills to adapt to rapid business goals; strong organizational skills, self-motivated, and thrive in a fast-paced and dynamic environment.

This role requires adaptability to change, and a commitment to fostering a culture of quality while making a meaningful impact at Velocity Bioworks .

• Maintain and administer the Training Program including conducting and coordinating employee training on applicable training curriculums and regulatory requirements.
• Participate in the development, implementation and continuously improvement of training programs for quality systems (e.g., GMP, GDP).
• Manage and maintain controlled documents, electronic forms and personnel training records within the company’s electronic quality management system (eQMS) and record retention location outside of eQMS.
• Create training curricula, assign training, track training completion and training activities for all personnel in the eQMS.
• Administer, track, and support the lifecycle management of nonconformances, deviations, investigations, and CAPAs within the eQMS.
• Collaborate with eQMS vendors and internal stakeholders to support system configurations.
• Provide publishing support for company documents in the creation of PDFs using eCTD format.
• Perform a quality review of controlled documents prior to release in the eQMS and verify the accuracy, correctness of formatting, styles, consistency and compliance with Velocity Bioworks’ document control standards.
• Perform risk assessments and facilitate control plans to prevent/resolve issues.
• Perform daily functions within the electronic document management system.
• Supports the maintenance, effectiveness and continuous improvement of quality systems processes, as needed.
• Review proposed changes impacting the validated state of quality systems through change control and coordinate review, implementation, and documentation of approved changes.
• Supports management review process through development, analysis and trending of quality systems metrics and escalate quality issues as required.
• Supports QMS representative during internal, client, and regulatory audits, supporting audit readiness, execution, and follow-up activities.
• Maintain and supports programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (CGMP).
• Author, review, and implement changes to controlled documents (e.g., SOPs, specifications, methods, and forms), as required.
• Provides guidance, technical expertise and mentorship to more junior staff and…