Quality Systems Lead - Compliance & Improvement

Prolacta Bioscience; California (MO); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Healthcare coverage

401(k) match

4 weeks PTO

parental leave

Affinity groups

Volunteer time off

Educational opportunities

Job summary

Prolacta Bioscience in California seeks a Supervisor for Quality Systems to oversee enterprise‑wide compliance within the Quality Management System. You will lead QA workflows, drive continuous improvement, and partner across departments to meet evolving quality objectives.

Responsibilities include supervising staff, maintaining QMS procedures, developing dashboards with Excel/Power BI, and supporting internal/external audits. Strong GxP and FDA knowledge are essential for success.

Qualifications

• BA/BS degree in business, science or technical field with a minimum of 5 years in Quality Systems in a regulated environment.
• Minimum 1 year of direct supervisory or team leadership experience.
• Knowledge of FDA regulations, ICH guidelines, and cGxP; familiarity with FDA 21 CFR parts 106, 107, 110, 117.
• Proficiency in data analysis and dashboards (Excel, Power BI) and root cause analysis methods.

Responsibilities

• Provide day-to-day supervision and troubleshooting support for Quality Systems staff, ensuring timely, accurate deliverables.
• Oversee development, implementation, and maintenance of QMS procedures and systems; standardize data collection and reporting protocols.
• Lead data-driven quality initiatives and manage Quarterly Management Review meetings; coordinate cross-functional efforts.
• Maintain controlled document lifecycle including authoring, reviewing, and approving SOPs, protocols, and reports.

Skills

Supervisory experience

Quality Systems

Data analysis

Excel

Power BI

GxP knowledge

Regulatory compliance

Education

BA/BS degree

Tools

MS Office

Job description

Prolacta Bioscience in California seeks a Supervisor for Quality Systems to oversee enterprise‑wide compliance within the Quality Management System. You will lead QA workflows, drive continuous improvement, and partner across departments to meet evolving quality objectives.

Responsibilities include supervising staff, maintaining QMS procedures, developing dashboards with Excel/Power BI, and supporting internal/external audits. Strong GxP and FDA knowledge are essential for success.