What are the responsibilities and job description for the Quality Assurance Manager for Plasma Facility position at Grifols?
Grifols is a global healthcare company dedicated to improving the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in over 110 countries and regions.
We're Grifols, an international plasma manufacturer headquartered in Barcelona, Spain. We serve healthcare professionals and patients in over 100 countries, with an unmatched record of product quality and safety, and are the largest plasmapheresis company in the world.
The Quality Systems Manager plays a critical role in ensuring that our plasma centers operate in compliance with all applicable regulations and standards. This position requires a strong understanding of quality management systems, regulatory requirements, and industry best practices.
Key Responsibilities:
- Evaluate processes and develop action plans to ensure center compliance with quality standards and regulations
- Collaborate with Center Managers to ensure product quality, donor suitability, and donor safety
- Direct and monitor processes to ensure center compliance with all applicable state, federal, and company-designated regulations
- Ensure that Standard Operating Procedures (SOPs) are properly interpreted, implemented, and followed by staff
- Interpret and implement processes, regulations, and SOPs for quality control and overall regulatory compliance
- Oversight of all aspects of internal and external audits, including execution, documentation, review, and preparation of responses
- Continuously assess, promote, and improve the effectiveness of quality systems in the donor center through recognition of trends, investigation of failures, direct employee observation, and review of center documents
