Quality Systems Manager

About the role

Join an international team working to improve the future of healthcare and enhance the lives of millions of people. Grifols is a global healthcare company that has been improving health and well-being since 1909. As leaders in plasma-derived medicines and transfusion medicine, we develop, produce, and market innovative medicines, solutions, and services in more than 110 countries and regions.

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 by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties.
• Directs and monitors processes to ensure 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 the center training program, ensuring compliance with program requirements to promote staff competency in their assigned job duties.
• Maintains and audits training records and files.
• Collaborates with the Center Manager to ensure the donor center operates in a manner that assures product quality, donor suitability, and donor safety.
• Oversees personnel functions of the Quality Systems Associate, including direction, work assignment, hiring, development, training, disciplinary actions, termination, maintenance of personnel records, work schedules, and delegation/follow-up of tasks.
• Oversees all aspects of internal and external audits, including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up.
• Continuously assesses, promotes, and improves the effectiveness of quality and training systems through recognition of trends, investigation of failures in procedure execution, and direct observations.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically relating to donor safety and product quality.
• Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure effectiveness.
• Oversees product and biohazard waste shipments, ensuring shipments meet regulatory specifications and product release requirements, accurate labeling and documentation, and authorizes final shipment.
• Reviews documentation of unsuitable test results and unit lookback information.
• Reviews donor adverse event reports and related documentation.
• Ensures completion, documentation, and filing of job and center annual training (e.g., Advanced cGMP, Blood Borne Pathogen, and others as required).
• Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
• Ensures all supplies and materials meet quality requirements prior to use and are stored in appropriate temperature/facility conditions; initiates investigations if requirements are not met and rejects non-conforming supplies.
• Determines donor suitability activities and manages donor deferrals as appropriate.
• Reviews and approves deferred donor reinstatement activities.
• Prepares quality analysis reports to track issues and set goals.
• Conducts in-depth research and analysis to resolve systemic compliance issues.
• Ensures proper documentation of Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training.
• Holds monthly Quality Meetings to communicate status updates and manage action outcomes.

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.

Skills

• Command of interpersonal communication, organizational, and problem-solving abilities.
• Ability to understand and assess FDA 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 minimal supervision.
• Ability to travel when needed for meetings, events, and occasional support of other centers.

Occupational Demands

• 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 32 degrees F, miscellaneous production chemicals, moving machinery, and production equipment.
• Exposure to high levels of noise on the production floor.
• Personal protective equipment required such as protective eyewear, garments, and gloves.
• Frequently sits for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasionally walks, bends, and twists neck.
• Light to moderate lifting and carrying objects with a maximum lift of 35 lbs.
• Frequently drives to site locations with occasional travel within the United States.
• Able to communicate complex information and ideas so others will understand; ability to listen to and understand information and ideas presented through spoken words and sentences.
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
• Frequently interacts with others, relates sensitive information to diverse groups, and must work with diverse groups to obtain consensus on issues.
• Ability to apply abstract principles to solve complex conceptual issues.

Benefits

• Medical benefits.
• Paid Time Off (PTO).
• Up to 5% 401K match.
• Tuition reimbursement.
• Opportunities for professional growth and career progression.

Grifols is committed to offering employees a family-like culture and opportunities for growth within a global healthcare company.