Quality Manager

Overview

Would you like to join an international team working to improve the future of healthcare? Grifols is a global healthcare company since 1909 committed to improving the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. We are Grifols, an international plasma manufacturer headquartered in Barcelona, Spain. We serve healthcare professionals and patients in over 100 countries, with a record of product quality and safety, and we are the largest plasmapheresis company in the world.

If you enjoy working in an environment built around teamwork and trust, consider your career with us as a QUALITY SYSTEMS MANAGER

Job Title : QUALITY SYSTEMS MANAGER

Summary

Evaluates processes, develops action plans, and coordinates the strategic implementation of system processes and corrective actions.

Primary Responsibilities for Role

• Independent level of quality inspection and control – ensures center compliance with quality standards and regulations.
• Collaborates with Center Managers to ensure product quality, donor suitability and donor safety.
• Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations.
• Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs.
• Interprets and implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required.
• Oversees all aspects of internal and external audits including execution, documentation, review and preparation of responses, and implementation of corrective and preventive actions with follow-up as required.
• Continuously assesses, promotes, and improves the effectiveness of the quality systems in the donor center through trend recognition, investigation of failures, direct employee observation, and review of center documents.
• Responsible for the personnel functions of the Quality Systems Associate(s); including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule management, and task delegation / follow-up.
• Oversees product and biohazard waste shipments : ensures regulatory specifications and product release, labeling and documentation, and authorizes final shipment.
• Reviews documentation of unsuitable test results and the disposition of associated results.
• Works with the Center Manager to develop staff knowledge of their job function and how performance relates to the end product and patient.
• Documents, investigates, and performs root cause analysis for deviations and customer complaints related to donor safety and product quality.

Other Responsibilities for Role

Job Requirements

Education

Experience

Equivalency

Depending on the area of assignment, directly related work experience or a combination of directly related education and experience and / or competencies may be considered in place of the stated requirements.

Knowledge, Skills & Abilities

Interpersonal communication, organizational and problem-solving abilities; understanding of FDA regulations; strong integrity and commitment to quality and compliance; mathematics literacy; legible handwriting; high computer proficiency; proficiency in root cause analysis and corrective / preventive actions; ability to balance multiple priorities; strong time management; capability to work with minimal supervision; willingness and ability to travel for meetings, events, and occasional support of other centers.

Occupational Demands

Work is performed in an office and / or a laboratory / manufacturing environment with exposure to biological fluids and potential infectious organisms; exposure to electrical equipment; cold environments; chemicals; and production machinery. PPE is required. Regularly seated for long periods; repetitive hand movements; occasional walking, bending, twisting; lifting up to 35 lbs; occasional travel within the United States. Ability to communicate complex information clearly and work with diverse groups; ability to plan and execute independently.

Compensation and Benefits

The estimated pay scale for the Quality Systems Manager in Moreno Valley, CA is $70k - $100k per year. The position is eligible for up to 20% of the company bonus pool. Benefits include medical, dental, vision, PTO, up to 5% 401(K) match, and tuition reimbursement. Final compensation depends on education, experience, skillset, knowledge, location, internal equity and market data.

Grifols is a global healthcare organization with employees in 30 countries and a family-like culture. Since 1909, Grifols has grown and offers opportunities for career progression.

Location : NORTH AMERICA : USA : CA-Moreno Valley

Contact : Alex S. Contreras, Staffing Partner III - (213) 219-5494 acontreras@grifols.com

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