Quality Systems Lead – Regulatory & CAPA Excellence

RXinsider LTD.; Oklahoma; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Sign-on bonus

Relocation assistance

Job summary

Grifols is seeking a QUALITY SYSTEMS MANAGER to oversee the center's quality system, drive improvements, and ensure regulatory compliance. The role reports to the Regional Quality Manager and collaborates with the Center Manager to maintain product quality and donor safety.

Responsibilities include audits, CAPAs, training oversight, and documentation management. Requires 2–5 years in a cGMP environment and a BS degree; sign-on bonus and relocation assistance are offered.

Qualifications

• Bachelor of Science degree or equivalent required.
• Certified and proficient in quality and compliance.
• 2–5 years of related experience in a medical and/or cGMP regulated environment.
• Experience with plasma or whole blood.

Responsibilities

• Maintain oversight of the quality management system and drive continuous quality improvement.
• Ensure center compliance with applicable state, federal regulations and SOPs.
• Collaborate with Center Manager to assure product quality, donor suitability and safety.
• Oversee personnel functions of Quality Systems Associate including hiring and training.
• Oversee audits, corrective/preventive actions, and regulatory follow-up.
• Lead training, document control, and deviations investigations.

Skills

Interpersonal communication

FDA regulations

Root cause analysis

Quality & compliance

Time management

Education

Bachelor of Science degree or equivalent

Certified in quality and compliance

Job description

Grifols is seeking a QUALITY SYSTEMS MANAGER to oversee the center's quality system, drive improvements, and ensure regulatory compliance. The role reports to the Regional Quality Manager and collaborates with the Center Manager to maintain product quality and donor safety.

Responsibilities include audits, CAPAs, training oversight, and documentation management. Requires 2–5 years in a cGMP environment and a BS degree; sign-on bonus and relocation assistance are offered.