Supervisor, Quality Systems

Do you want to contribute to a larger purpose to save the lives of infants in the NICU? This is Prolacta Bioscience’s mission! Take a look at this opportunity with our Quality Assurance team, which is seeking a passionate individual, to fill the role of our Supervisor, Quality Systems position. The Supervisor, Quality Systems is responsible for overseeing and ensuring enterprise-wide compliance and operational excellence within the Quality Management System (QMS) at Prolacta Bioscience. This role overseas the execution of quality workflows, drives continuous improvement, and supports alignment with state and federal regulatory requirements across all departments. The Supervisor provides experienced guidance, supervises team performance, and partners cross-functionally to meet evolving business and quality objectives. Who is Prolacta Bioscience? We give babies a brighter future by unlocking the biological power of human milk. Established in 1999, Prolacta Bioscience is a privately held life sciences company that has touched the lives of more than 100,000 premature infants globally. Prolacta is the world’s leading hospital provider of 100% human milk– based nutritional products. Based in Southern California, we employ more than 300 people globally, many of whom have dedicated their lives to neonatal care. This role will provide you with the opportunity to contribute to the growth of our organization and develop your professional skills by performing the following… Supervision/ Management Provide day-to-day supervision, decision-making, and troubleshooting support for various activities performed by Quality Systems staff. Ensure consistency, accuracy, and timely execution of deliverables. Communicate job and performance expectations by planning, monitoring, and evaluating results; coaching, counseling, and motivating employees; initiating, coordinating, and enforcing systems, policies, and procedures. Maintain staff effectiveness by orienting and training employees; developing personal growth opportunities. Technical Skill Sets/QA/Compliance 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 What you bring to the role 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. 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 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. How Prolacta benefits you To drive the personal growth and business impact of our employees, we’re committed to developing a supportive and enriching culture for everyone. From up to 100% healthcare coverage starting on your first day and 401(k) match, we value our employees’ health and financial wellbeing. We offer four weeks PTO during your first year of employment and support our new parents with a generous time-off program. We encourage employees to participate in our employee affinity groups, take volunteer time off, and provide access to different educational opportunities. What else do you need to know Location: Onsite, City of Industry and Duarte offices Travel: 10% FLSA: Exempt Depending on your residential location certain laws might regulate the way Prolacta manages applicant data. California Residents, please review our Privacy Notice for California Employees and Job Applicants for further information, this can be found on Prolacta.com on . By submitting your application, you are agreeing and acknowledging that you have read and understand the above notice. Physical Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to effectively communicate (e.g., talking/ hearing), walk, sit, use hands and fingers to handle, feel and reach things. The employee is occasionally required to taste, smell, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus. Sedentary to light work; repetitive motions; pushing; pulling; visual acuity to prepare and analyze data and figures, transcribe, view a computer terminal. EEO Statement “Prolacta Bioscience, Inc. is an Equal Employment Opportunity Employer.” Prolacta Bioscience, Inc. is committed to a proactive program of affirmative action and diversity development. The Company will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.

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