Purpose

Kamada Plasma is Growing! Join our expanding team at Kamada Plasma, a subsidiary of Kamada Ltd, as we open our state-of-the-art Nexus Center in San Antonio in February 2025! 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 Director and collaborates closely with the Center Manager to foster a culture of continuous improvement.

We offer a competitive compensation package, including a base salary commensurate with experience, medical, dental and vision coverage, 401k matching, holidays, and PTO. 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.

Kamada Plasma is an equal opportunity employer that prohibits discrimination based on race, color, religion, sex, national origin, age, disability, or any other legally protected status. Qualified individuals of all backgrounds are encouraged to apply now and be part of our mission to save lives!

As part of our commitment to a safe workplace, Kamada conducts pre-employment background checks. By applying for a position, you agree to participate in the background check process if selected as a finalist. Results will be kept confidential, and non compliance or negative results may effect employment eligibility.