Center Quality Manager
BPL Plasma is dedicated to the collection of plasma for life-saving therapies. For over 25 years, our product has been used to treat immune deficiencies and bleeding disorders, in addition to shock, trauma, and burn patients. BPL Plasma currently operates 34 FDA licensed blood plasma collection centers throughout the United States. We are opening new centers and growing rapidly in order to provide even more life-saving treatments to those in need.
The purpose of this position is to manage quality standards within the center and ensure that quality policies and procedures are followed by center personnel. The Center Quality Manager has the authority to stop production and/or plasma shipment release based on his/her professional judgment and discretion.
Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.
• Manages center Quality Assurance Supervisor and Quality Assurance Alternate to include training, performance evaluation, compensation administration and progressive discipline as needed according to company policies and procedures.
• Coordinates the scheduling of the Quality Assurance Supervisor and Quality Assurance Alternate.
• Trains and develops center QA staff.
• Analyzes tracking and trending data and determines appropriate actions to improve center operations.
• Plans and presents quality topics during regularly scheduled staff meetings and conducts regular meetings with center QA staff.
• Manages timely resolution of error investigations and CAPA.
• Drives center level CAPA initiatives generated from KPI analysis.
• Reviews manufacturing activities, determines if manufacturing records are in compliance with SOP and regulatory requirements; ensures corrective actions as needed.
• Performs final QA review and release for all product shipments and associated documents in order to ensure shipments meet regulatory customer specifications as needed.
• Manages daily quality assurance/quality control issues affecting donor suitability and/or product quality; develops and implements corrective actions when necessary.
• Co-hosts customer, regulatory, and corporate audits of the center. In conjunction with regional and center management, completes all audit responses, including corrective/preventive action, and ensures that responses are submitted in a timely manner.
• Reviews and identifies CAPA initiatives based on data from the ongoing center level compliance assessments.
• Ensures that training for SOP changes occurs and is effective via staff performance observations.
• Ensures that QA staff accurately reviews center logs and records as outlined in the Quality System SOP.
• Other job related responsibilities as required.