Quality Systems Leader: Compliance & Continuous Improvement

Prolacta Bioscience; Duarte (CA); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Healthcare coverage

401(k) match

4 weeks PTO

Job summary

Prolacta Bioscience seeks a Supervisor, Quality Systems to oversee enterprise-wide quality workflows within the QMS. You will guide staff, ensure regulatory alignment, and drive continuous improvement across departments.

This role requires strong knowledge of FDA regulations, GxP, and data-driven quality management. You will lead audits, manage controlled documents, and partner with IT to optimize QMS tools while training teams and promoting lean practices.

Qualifications

• BA/BS in business, science or technical field with at least 5 years in Quality Systems in a regulated environment.
• Minimum 1 year of direct supervisory or team leadership experience.
• Knowledgeable with FDA regulations, ICH guidelines and cGxP principles; familiarity with 21 CFR sections is preferred.
• Proficiency in data analysis and dashboards using tools like Excel and Power BI.
• Experience developing and maintaining controlled documents and leading quality initiatives.

Responsibilities

• Provide day-to-day supervision and coaching for Quality Systems staff, ensuring timely deliverables.
• Oversee QA/Compliance programs, adapt QMS procedures, and drive continuous improvement.
• Manage dashboards, data analysis, and performance reporting; lead root cause analyses.
• Coordinate audits, inspections, andCAPA processes; ensure audit readiness and corrective actions.
• Lead cross-functional quality initiatives and collaborate with IT to optimize QMS tooling.
• Develop and deliver advanced training on Quality Systems and regulatory requirements.

Skills

Quality Systems

Supervisory experience

FDA regulations

Data analysis

GxP compliance

Education

BA/BS in related field

Tools

MS Office

Power BI

Job description

Prolacta Bioscience seeks a Supervisor, Quality Systems to oversee enterprise-wide quality workflows within the QMS. You will guide staff, ensure regulatory alignment, and drive continuous improvement across departments.

This role requires strong knowledge of FDA regulations, GxP, and data-driven quality management. You will lead audits, manage controlled documents, and partner with IT to optimize QMS tools while training teams and promoting lean practices.