Center Quality Manager

Purpose

We're looking for a skilled Center Quality Manager to oversee the daily quality operations and share our mission to significantly impact global healthcare and save lives through the collection of rare donor human plasma. The Center Quality Manager must be dedicated, detail-oriented, collaborative, and forward thinking to ensure the highest standards of quality, safety, and compliance. This position reports to the US Plasma Quality Manager and collaborates closely with the Center Manager to foster a culture of continuous improvement.

Benefits

401(k) matching

Dental insurance

Health insurance

Paid time off

Holidays

This full-time position requires a minimum of 40 hours per week at the center and is not eligible for overtime.

Key Responsibilities

Record Reviews

Conduct thorough reviews of quality-related records to ensure compliance with regulations and internal policies.Address discrepancies and nonconformities promptly and appropriately.Record and monitor quality incidents, escalating critical incidents to the US Plasma Quality Manager as needed.

GEMBA Walks And Direct Observation

Perform regular GEMBA walks and direct observation of production processes.Provide immediate feedback and corrective actions.Collaborate with staff on process improvement initiatives.

Deviation And CAPA Management

Investigate and document deviations, ensuring timely resolution and preventive measures.Lead the management of deviations, incidents, and corrective and preventive actions (CAPAs).Implement corrective and preventive actions based on deviation analysis.

Nonconformance Tracking And Trending

Continuously track and analyze nonconformances to identify trends and systemic issues.Develop strategies to address recurrent issues and reduce nonconformances.Halt production processes when necessary to address nonconformances.

Quality Council Meetings

Organize and facilitate routine Quality Council meetings to discuss key quality indicators and improvement initiatives.Collaborate with cross-functional teams on quality-related decisions.

Audits

Plan, execute, and document internal audits to ensure SOP and quality standard compliance.Identify improvement areas and propose corrective actions.Coordinate internal and external audit processes, managing preparations and addressing audit findings promptly.

Qualifications

High school diploma or GED required; bachelor's degree preferred.Three to five years of experience in a regulated environment, preferably in a plasma collection center.Certification in quality management or auditing is a plus.Knowledge of FDA regulations, GMP, PPTA, and CLIA standards.Proficiency in quality management software and tools, including Excel.Experience in conducting audits and facilitating regulatory inspections is advantageous.Excellent communication, interpersonal, and organizational skills.Ability to work effectively with diverse stakeholders and manage multiple priorities.Physical ability to stand, sit, walk, lift at least 25 lbs, handle biohazardous materials, and work in a fast-paced environment.