Quality Systems Supervisor: Compliance & Improvement

Valid8 Financial, Inc.

Duarte (CA)

On-site

USD 110,000 - 160,000

Full time

14 days+

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Benefits offered by this job

Healthcare Coverage

401(k) match

Paid time off

Job summary

Prolacta Bioscience, Inc. is seeking a Supervisor, Quality Systems to oversee enterprise-wide compliance within the Quality Management System.

The role drives continuous improvement, quality workflows, and regulatory alignment across departments while guiding a team of Quality Systems professionals. You will supervise document control, training, audits, dashboards, and metrics, partnering with IT to optimize QMS software and data integrity, with a strong focus on risk reduction and quality

Qualifications

BA/BS degree in a business, scientific or technical discipline with a minimum of 5 years in Quality Systems or relevant experience in a regulated environment.
A minimum of 1 year of direct supervisory or team leadership role.
Knowledgeable with FDA regulations, ICH Quality guidelines, and cGxP principles.
Proficiency in data analysis tools (e.g., Excel, Power BI) and statistical methods for root cause analysis and trend evaluation.
Proficient at computer usage including MS Office (Word, Excel, PowerPoint, Access and Visio) required.
Experience developing and maintaining dashboards, metrics reports, and performance indicators to support continuous improvement and compliance.
Proven experience managing document control systems and authoring, reviewing, and approving controlled documents including SOPs, protocols, reports, and batch records.
Demonstrated ability to lead cross-functional quality initiatives.
Training in GxP, ISO standards, or regulatory compliance frameworks (FDA, EMA, etc.) is highly desirable.
Certification in Quality Management (e.g., ASQ CQIA, CQPA, or Six Sigma Green Belt) strongly preferred.

Responsibilities

Supervision/ Management
Oversee development, implementation, and maintenance of quality, safety, and GxP procedures and systems within the team.
Maintain and continuously improve the Quality Metrics program, including dashboard development, data analysis, and performance reporting.
Lead data-driven Quality improvement initiatives using root cause analysis and basic statistical tools to identify inefficiencies and recommend corrective actions. Facilitate the Quarterly Management Review meetings.
Standardize data collection and reporting protocols to support consistent, accurate, and compliant quality operations.
Coordinate cross-functional efforts to evaluate, strengthen, and sustain Quality Excellence.
Recommend and implement quality strategies that mitigate compliance risks, enhance system efficiency, and support business objectives.
Act as the primary liaison between Quality Systems and other departments, fostering collaboration and resolving operational challenges.
Partner with IT to support evaluating and optimizing QMS software functionality and process automation while maintaining data integrity.
Oversee controlled document lifecycle, including authoring, reviewing, and approving SOPs, protocols, reports, and operational documentation assigned to meet internal and external standards and regulatory expectations.
Design and deliver advanced training programs for Quality Systems and broader teams. Continuously assess and improve training effectiveness.
Represent Quality Systems during internal and external audits, inspections, and walkthroughs. Ensure audit readiness and timely resolution of findings.
Promote lean principles, 5S methodology, and proactive risk management across the Quality organization.
Perform other duties as assigned