Supervisor, Quality Systems

About the Company

Prolacta Bioscience gives babies a brighter future by unlocking the biological power of human milk. Established in 1999, Prolacta is a privately held life sciences company that has touched the lives of more than 100,000 premature infants globally. As the world’s leading hospital provider of 100% human milk–based nutritional products, Prolacta employs over 300 people globally, many dedicated to neonatal care.

About the Role

The Supervisor, Quality Systems oversees and ensures enterprise-wide compliance and operational excellence within the Quality Management System (QMS) at Prolacta Bioscience. This role supervises the execution of quality workflows, drives continuous improvement, and supports alignment with state and federal regulatory requirements across all departments. The Supervisor provides guidance, manages team performance, and partners cross-functionally to meet evolving business and quality objectives.

Responsibilities

• Provide day-to-day supervision, decision-making, and troubleshooting support for Quality Systems staff.
• Ensure consistency, accuracy, and timely execution of deliverables.
• Communicate job and performance expectations; plan, monitor, and evaluate results; coach, counsel, and motivate employees; enforce systems, policies, and procedures.
• Maintain staff effectiveness by orienting and training employees; develop personal growth opportunities.
• Oversee development, implementation, and maintenance of quality, safety, and GxP procedures and systems.
• 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 statistical tools to identify inefficiencies and recommend corrective actions.
• Facilitate 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 evaluate and optimize 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 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.

Requirements

• 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.
• Minimum of 1 year of direct supervisory or team leadership experience.
• Knowledgeable with FDA regulations, ICH Quality guidelines, and cGxP principles.
• Knowledge of FDA 21 CFR 106, 107, 110, and 117 is highly desired.
• Proficiency in data analysis tools (e.g., Excel, Power BI) and statistical methods for root cause analysis and trend evaluation.
• Proficient in MS Office (Word, Excel, PowerPoint, Access, and Visio).
• 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.

Benefits

• Up to 100% healthcare coverage starting on your first day.
• 401(k) match.
• Four weeks PTO during your first year of employment.
• Generous time-off program for new parents.
• Employee affinity groups and volunteer time off.
• Access to educational opportunities.

Schedule

This is a full-time, exempt position requiring onsite work at the City of Industry and Duarte offices. Travel is estimated at 10%.

Physical Requirements

The physical demands described are representative of those required to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Regularly required to communicate effectively (e.g., talking/hearing), walk, sit, use hands and fingers to handle, feel, and reach.
• Occasionally required to taste, smell, stoop, kneel, crouch, or crawl.
• Specific vision abilities include close vision, color vision, and the ability to adjust focus.
• Sedentary to light work involving repetitive motions, pushing, pulling, and visual acuity to prepare and analyze data, transcribe, and view a computer terminal.