Plasma Center Quality Systems Manager

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve 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.

Quality Systems Manager (QSM)

PRIMARY RESPONISBILITIES
- Directs and monitors processes and ensures center compliance with all regulations as mandated by the applicable regulatory authorities and company policies.
- Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance.
- Collaborates with the Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained.
- Directly supervises the Quality Systems Associates.
- Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, development and implementation of corrective/preventative (CAPA) actions, development and assessment of CAPA effectiveness
- Assesses, promotes, and improves the effectiveness of quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct
- Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.
- Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness.
- Oversees product and biohazard waste shipments: Ensures shipments meet regulatory and customer specifications and product release requirements; ensures accurate labeling and documentation.
- Ensures that documentation of unsuitable test results, unit lookback information, and all associated actions is complete and reviewed.
- Ensures that donor adverse event reports and the applicable related documentation is complete and reviewed.
- Ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as required) is completed, documented, and on file.
- Performs periodic employee performance observations to ensure staff competency..
- Ensures all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions. Working with Center Management, initiates appropriate investigations for any non-conformances and anomalies.
- Ensures donor and other production records are reviewed and donors are deferred and reinstated according to approved procedures.
- Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues.
- Holds monthly quality meetings with Center Management to communicate status updates and manage action outcomes.
- Working with Center Management, performs other duties as needed to ensure donor and product safety at the center.

**JOB REQUIREMENTS**:

- Bachelor of Science degree or equivalent.
- Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate degree with 6 years of experience, or a master’s degree with 2 years of experience.
- Typically requires 2 years of related experience in a medical and/or cGMP regulated environment. Experience with plasma or whole blood preferred.

**KNOWLEDGE, SKILLS, AND ABILITIES**:
Command of interpersonal communication, organizational and problem-solving abilities. Ability to understand and assess FDA, Health Canada, and EMA regulations. Strong integrity and commitment to quality and compliance. Full command of mathematics. Legible handwriting. High level of proficiency with computers. Proficient in root cause analysis and corrective/preventative actions. Ability to balance multiple competing priorities. Strong time management abilities. 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 mínimal supervision. Ability to travel when needed for meetings, events, and occasional support of other centers.

Occupational Demands Form # 6: Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below minus 20oC (-20oC), miscel