Hendersonville Center Quality Manager NC 28791

Job description

KEDPLASMA is a subsidiary of Kedrion Biopharma Inc. KEDPLASMA specializes in the collection and procurement of high-quality plasma that is processed into plasma-based therapies. Kedrion Biopharma Inc. is an international company specializing in the collection and fractionation of blood plasma to produce and distribute plasma-derived therapeutic products. Our therapies help treat and prevent serious diseases, including Hemophilia, Primary Immune System Deficiencies, and Rh-Sensitization. Job Summary Are you a quality-driven leader with a passion for compliance and operational excellence? Join our team as a Quality Assurance Manager and take ownership of ensuring that plasma collection operations meet the highest standards of safety, accuracy, and regulatory compliance. In this role, you’ll lead quality initiatives, manage audits, and empower your team to uphold the integrity of life-saving plasma products. As the Quality Assurance Manager, you’ll collaborate with the Center Manager and oversee all quality-related activities, including documentation, training, product release, and regulatory readiness. You’ll be a key decision-maker with the authority to stop production or shipments when necessary to protect donor safety and product quality. What You'll Do: Oversee all quality operations at the plasma center, ensuring compliance with FDA, EU GMP, cGMP, and internal standards. Review plasma collection records and activities to verify accuracy and adherence to SOPs. Investigate deviations and implement corrective actions to maintain compliance. Conduct audits and evaluations of procedures, equipment, and documentation. Monitor and report test results, quality control records, and preventive maintenance logs. Evaluate staff competency through direct observation, written assessments, and proficiency testing. Ensure proper documentation and recordkeeping for all quality-related activities. Oversee plasma release and shipment verification, ensuring all specifications are met. Lead CLIA proficiency testing, complaint investigations, and certification tracking. Analyze quality data and trends to identify opportunities for improvement. Maintain readiness for internal and external audits and inspections. Collaborate with leadership to promote a culture of continuous improvement and regulatory excellence. Qualifications: Bachelor’s degree in healthcare, life sciences, or a related field preferred (or equivalent experience). 3–5 years of experience in the plasma industry or biomedical field preferred. Minimum 1 year of experience in a regulated industry; cGMP experience strongly preferred. Strong understanding of FDA, EU, and industry regulations. Excellent organizational, analytical, and documentation skills. Proficiency in Microsoft Office and familiarity with data entry and recordkeeping systems. Ability to lead teams and manage multiple priorities in a fast-paced environment. Comfortable working in regulated settings with exposure to bloodborne pathogens and cold storage areas. Willingness to travel to other plasma centers and Kedrion locations as needed. Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future. Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Salary ranges are determined based on relevant experience, education, and certifications. If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team at kedtalent@kedrion.com . Employee Benefits: At Kedrion Biopharma Inc., we believe in taking care of our people. Our benefits package is designed to support your health, happiness, and future, including: Health & Wellness – Full medical, dental, and vision coverage Financial Security – Life insurance, AD&D, and retirement savings plans Work-Life Balance – Paid time off, sick leave, and paid holidays Career Growth – Training programs and development opportunities Extra Perks – Employee discounts, wellness initiatives, and more! For specific inquiries please reach out to us Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. 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