Quality Systems Coordinator

The Quality Systems Coordinator supports the maintenance and execution of the Quality Management System (QMS) to ensure compliance with cGMP and regulatory requirements within a cell and gene therapy environment. This role is responsible for coordinating quality system processes, maintaining documentation, supporting investigations, and facilitating continuous improvement activities.

DUTIES AND RESPONSIBILITIES:

The following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned.

- Maintain controlled documents and training records within eQMS

- Coordinate and maintain Quality Systems including deviations, CAPA, change control, and document control

- Ensure accurate and timely documentation in alignment with cGMP requirements

- Track and report quality system metrics and KPIs

- Support investigations and root cause analysis activities

- Assist with CAPA tracking and effectiveness checks

- Support internal and external audits and regulatory inspections

- Coordinate cross-functional communication related to quality systems

- Identify opportunities for continuous improvement and support implementation

- Ensure compliance with internal procedures and regulatory requirements

QUALIFICATIONS:

- Bachelor's degree in Life Sciences, Engineering, or related field (or equivalent experience)

- 2-5 years of experience in Quality, preferably in pharmaceutical, biotech, or cell & gene therapy industry

- Familiarity with Quality Systems (CAPA, deviations, change control)

- Knowledge of cGMP and regulatory expectations

- Experience with electronic Quality Management Systems (eQMS) preferred

- Strong organizational and documentation skills

PHYSICAL DEMANDS:

Frequently required to stand

Frequently required to walk

Frequently required to sit

Frequently required to talk or hear

Occasionally required to lift light weights (less than 25 pounds)

Specific vision abilities required include close vision, color vision and ability to adjust focus

WORK ENVIRONMENT:

The noise level in the work environment usually is quiet.

Work may be performed in office, laboratory, or GMP manufacturing environments.

Equal opportunity employer, and does not discriminate on the basis of race, color, religion, sex, pregnancy, national origin, disability, age, genetic information, veteran status, sexual orientation, gender identity or any other characteristic protected by federal, state or local law.