We are seeking a Field Quality Manager to join our growing biopharmaceutical company. Reporting into the Director of Field Quality, this position promotes quality standards for the plasma centers and ensures that corporate quality policies and procedures are followed by center personnel.
Additional responsibilities of the Field Quality Manager role include:
Serves as a quality liaison between Field Quality Director and center operations in matters of quality. Ensure consistent compliance with FDA, EU, OSHA, PPTA, customer and other regulatory authorities. Provides support to field operations in achieving company goals while complying with regulatory requirements and driving quality excellence.
Develops and fosters a philosophy of continuous improvement in all centers. Implements and consistently promotes the philosophy that compliance in quality, safety and training is essential to successful operations.
Represents corporate during regulatory audits/inspections and provides responsive leadership during the course of the audit.
Interacts with Donor Center and appropriate OPI personnel to facilitate corrective and preventative actions for inspection findings.
Assists Donor Centers in preparing for audits and provides direction in development of written responses.
Support Regional Directors in development of CAPAs for internal and external audits.
Analyzes deviation and audit tracking and trending data for systemic issues and develops effective preventive actions.
Prepares, edits, and revises standard operating procedures and policies based on needed process improvements and/or changes in regulatory requirements.
Drives Communication up and down the organization. Builds partnerships that support and encourage participation and innovation in creating problem solving strategies that enable the region to meet corporate objectives.
Conducts regularly scheduled meetings with center quality staff to continuously develop, monitor and evaluate quality staff training and development.
Support the center's ongoing quality training and education through routine training sessions.
Qualified candidates of this role must offer a minimum of three years experience a biologics, drug manufacturing, medical device or FDA regulated facility. You must offer strong organizational skills, attention to detail and excellent writing skills.
Other requirements of the Field Quality Manager role include:
Bachelor’s degree in one of the allied sciences (chemistry, biology, medical technology) is preferred. Other combinations of education and experience may be considered.
2 years’ supervisory experience is strongly preferred.
Octapharma Plasma, Inc. owns and operates plasma collection centers throughout the United States. Our services are critical to the development of life-saving patient therapies utilized by thousands of patients all over the world. Octapharma Plasma is a subsidiary of one of the world’s largest plasma products manufacturers, Octapharma AG, a Switzerland-based company that has been committed to patie...nt care and medical innovation for over 30 years. Octapharma employs over 5,000 people and has biopharmaceutical experience in 70 countries worldwide. Octapharma Plasma, Inc.'s most important asset is our plasma donors, many of whom have donated at our plasma donor centers for many years. Octapharma takes great pride in the safety record and customer service afforded to all donors.