Global Quality Systems Lead - Compliance & Training

Grifols; Greenville (SC); Sur place; USD 110 000 - 150 000; Plein temps

Avantages offerts par ce poste

Medical benefits

Paid time off (PTO)

401K match up to 5%

Tuition reimbursement

Résumé du poste

Grifols is seeking a Quality Systems Manager (QSM) to lead the plasma donor center's quality program, ensure regulatory compliance, and drive continuous improvement across QA processes. The role emphasizes SOP implementation, training oversight, and audit management to safeguard product quality and donor safety.

The position requires a BS degree or equivalent with 2+ years in a regulated environment; travel to sites nationwide is possible.

Qualifications

• Bachelor of Science degree or equivalent; equivalency considered (education/experience may be combined)
• Typically requires 2 years of related experience in a medical and/or cGMP regulated environment; plasma or whole blood experience preferred.

Responsabilités

• 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 and ensures center compliance with all applicable state, federal, and company-designated regulations. Implements SOPs for quality control and regulatory compliance.
• Maintains oversight of center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties. Maintains and audits training records and files.
• Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained.
• Responsible for the personnel functions of the Quality Systems Associate; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule and delegation/follow-up of tasks.
• Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up as required.
• Continuously 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 observations.
• 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 specifications and product release requirements; ensures accurate labeling and documentation and authorizes final shipment.
• Performs a review of the documentation of unsuitable test results and unit lookback information.
• Performs a review of donor adverse event reports and the applicable related documentation.
• 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 employee training observations to ensure staff competency prior to releasing employees to work independently.
• Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions. Initiates appropriate investigations if these requirements are not met. Initiates rejection of supplies for non-conformance.
• Determines donor suitability activities and manages donor deferrals as appropriate. Reviews and approves of deferred donor reinstatement activities.
• Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues.
• Ensures that CLIA proficiency test surveys, complaint investigations, and training have been properly documented.
• Holds monthly Quality Meeting to communicate status updates and manage action outcomes.

Connaissances

Interpersonal communication

Organizational skills

Problem solving

FDA regulations

Quality and compliance

Mathematics

Computers

Root cause analysis

Prioritization

Time management

Minimal supervision

Travel

Formation

BS degree or equivalent

2+ years related experience

Description du poste

Grifols is seeking a Quality Systems Manager (QSM) to lead the plasma donor center's quality program, ensure regulatory compliance, and drive continuous improvement across QA processes. The role emphasizes SOP implementation, training oversight, and audit management to safeguard product quality and donor safety.

The position requires a BS degree or equivalent with 2+ years in a regulated environment; travel to sites nationwide is possible.