Quality Assurance Manager

Overview

The Quality Assurance Manager is responsible for the day-to-day execution and maintenance of the Lions World Vision Institute (LWVI) Quality Management System, ensuring operational compliance with FDA HCT/P requirements, accreditation standards, and internal policies. Reporting to the Quality Assurance Director, this role provides hands-on leadership for quality processes, investigations, audits, training, and continuous improvement initiatives, while partnering with operational teams to identify and mitigate compliance risks.

The Quality Assurance Manager plays a critical role in maintaining inspection readiness, supporting safe and compliant operations, and advancing the organization’s mission and quality objectives.

This job description includes, but does not limit, the primary duties, qualifications, and scope of this role at LWVI.

• Oversee day-to-day execution of the Quality Management System (QMS) and ensure consistent implementation across operations.
• Manage and maintain controlled documents, records, and change control processes to ensure ongoing regulatory compliance.
• Lead investigations of deviations, nonconformances, adverse events, and complaints; perform root cause analysis and manage CAPA activities to closure.
• Coordinate and support regulatory inspections, audits, and assessments, including preparation, hosting support, response development, and follow-up actions.
• Plan and conduct internal audits and vendor/partner audits; track and verify timely completion of corrective actions.
• Supervise environmental monitoring, validations, and qualifications for facilities, equipment, and processes in collaboration with Operations.
• Ensure training and competency programs are executed, documented, and maintained in compliance with regulatory and accreditation requirements.
• Monitor quality metrics and trends; prepare reports and escalate risks, compliance issues, and improvement opportunities to the QA Director.
• Provide hands-on guidance to operational teams on SOP adherence, regulatory expectations, and quality best practices.
• Support continuous improvement initiatives and cross-functional projects as assigned by the QA Director.
• Maintain current knowledge of FDA, relevant state, and OSHA regulations as well as AATB and EBAA standards; keep informed on industry changes, trends, and best practices.

• Must have strong verbal, written, and analytical skills.
• Effective interpersonal skills: ability to develop and maintain positive relationships with professional contacts, resources and/or networks and deal with people with sensitivity, tact, discretion and professionalism.
• Experience with Microsoft Office Programs including:
  Word, SharePoint, Teams, Excel, Visio, etc.
• Strong investigative and problem-solving skills.
• Strong knowledge of quality management systems and audit methodologies.
• Exhibit a high degree of professionalism and etiquette.
• Must be able to effectively work independently and within a team.
• Able to manage time and prioritize constraints as well as the ability to manage multiple priorities/tasks simultaneously.
• Outcome driven; can thrive in a fast-paced environment while effectively managing pressure in a professional manner.

• Bachelor’s degree from an accredited four-year college or university preferred.
• Minimum of 5 years’ experience in quality or regulatory within tissue banking preferred.
• Minimum of 3 years’ experience in a leadership role preferred.
• Proven ability to train and mentor staff.
• Experience with the interpretation and practical application of FDA regulations, procedures, and guidelines that govern quality systems is preferred.
• Industry certifications (CEBT and CTBS) required, or must obtain both with 1 year of employment.
• ASQ CQA preferred.

The Quality Assurance Manager will periodically be required to travel by personal/company automobile, or air to meeting sites and other locations. Forty-hour work week. Must be available evenings, weekends, and holidays, when required.

The work is performed primarily in an office setting. The noise level in the work environment is moderate. The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related to a logical assignment to the position.

The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.