Quality Systems Supervisor

Job Description

Position Summary

We are seeking a Quality Systems Supervisor to lead and manage critical elements of our Quality Management System (QMS). This role is responsible for ensuring the effective implementation, maintenance, and continuous improvement of quality systems that support GxP compliance, including document control, training, CAPA, deviation management, and audits.

The ideal candidate will have strong knowledge of regulatory requirements (FDA, AATB, ISO), experience with electronic quality systems, and a hands-on leadership approach.

Key Responsibilities

Supervise and support day-to-day operations of core quality systems:

Document control

Training management

Deviations and investigations

CAPA

Change control

Internal/external audits

Create and revise standard operating procedures and protocols.

Investigate environmental monitoring quality events and determine primary root cause of organism introduction into the cleanrooms.

Ensure timely closure of quality records in accordance with internal procedures and regulatory expectations.

Partner with cross-functional departments (Manufacturing, QC, Regulatory) to drive quality initiatives and resolve compliance issues.

Train, mentor, and develop QA associates supporting quality systems activities.

Monitor QMS metrics and provide periodic reports to QA Management.

Support inspection readiness and participate in regulatory inspections and audits.

Contribute to continuous improvement initiatives to optimize quality system performance and compliance.

Qualifications Required:

Bachelor’s degree in life sciences, engineering, or related field.

5+ years of quality assurance experience in a GxP-regulated industry.

1–2 years in a leadership or supervisory role.

Strong understanding of quality system elements under FDA 21 CFR Part 1271, 210/211, 820.

Excellent technical writing, organizational, analytical, and interpersonal communication skills.

Preferred:

Knowledge of ISO 13485 and ISO 9001.

Lean Six Sigma or continuous improvement certification a plus.

Experience with electronic QMS platforms (e.g., Dot Compliance).

Full-time