Quality Systems Manager — Compliance & Process Excellence

Jobtailor; Houston (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

Jobtailor is seeking a Quality Assurance professional to oversee the plasma donor center's quality management system and drive compliance with regulatory requirements. The role focuses on evaluating processes, implementing SOPs, and coordinating corrective actions to ensure product quality and donor safety.

Key responsibilities include directing training, audits, and center operations in alignment with state, federal, and company standards, while collaborating with the Center Manager to maintain

Qualifications

• Bachelor of Science degree or equivalent.
• Typically requires 2 years of related experience in a medical and/or cGMP regulated environment.
• Experience with plasma or whole blood preferred.
• Ability to understand and assess FDA regulations.
• Strong integrity and commitment to quality and compliance.
• High level of proficiency with computers.
• Proven ability to maintain a high level of quality and compliance and to become a valuable member of the center leadership team.
• Ability to work with minimal supervision.

Responsibilities

• Evaluates processes, develops action plans, and coordinates the strategic implementation of quality system processes and corrective actions at the plasma donor center.
• Maintains oversight of the center’s quality management system and ensures continuous quality improvement.
• Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations.
• Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance.
• Maintains oversight of center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties.
• Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained.
• Responsible for the personnel functions of the Quality Systems Associate; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule and delegation/follow-up of tasks.
• Responsible for oversight of all aspects of internal and external audits.

Skills

FDA regulations

Quality systems

Quality control

Computer proficiency

Education

Bachelor of Science degree or equivalent

Job description

Jobtailor is seeking a Quality Assurance professional to oversee the plasma donor center's quality management system and drive compliance with regulatory requirements. The role focuses on evaluating processes, implementing SOPs, and coordinating corrective actions to ensure product quality and donor safety.

Key responsibilities include directing training, audits, and center operations in alignment with state, federal, and company standards, while collaborating with the Center Manager to maintain