Quality Manager Jobs

About The Position

Requirements

• Bachelor’s degree in a scientific discipline, life sciences, or a related discipline.
• At least 5 years of experience related to quality and regulatory work; plasma industry experience is specified.
• Demonstrated leadership or supervisory experience.
• Knowledge of government and industry regulations.

Responsibilities

• Keep the center inspection-ready by managing adherence to SOPs, compliance policies, and the quality system, and by addressing self-inspection findings and non-conformities.
• Prepare regular reports for center, area, and corporate quality management on the state of quality and systems at the center.
• Manage the site Quality Control program, including calibrations, process compliance monitoring, sampling, competency checks, KPIs, KPI trending and analysis, root-cause and failure-mode impact assessments, and change management.
• Lead and develop direct reports, ensuring they are competent to perform their QA roles; motivate and educate staff, and, following appropriate review, recruit, hire, conduct performance reviews, and take corrective action up to and including termination.
• Work with management to develop programs and methods that streamline center processes and improve customer and donor service, product yields, and financial results while maintaining compliance and quality.
• Give staff feedback on observations to improve GMP adherence; promptly report concerns or deficiencies to area personnel or management and recommend remedial actions.
• Serve as the key quality representative for site supplier, customer, and regulatory audits; lead center review of findings, coordinate remediation and CAPA as needed, and support timely audit closure.
• Use quality tools and applications to support issue understanding and documentation.
• Maintain a clean, efficient work environment and ensure operating supplies and forms are available as needed.
• Follow HSE and OSHA policies and procedures, conduct routine audits of internal procedures and documentation as necessary, and promote safety.
• Follow HR policies and practices, treat employees fairly and equitably, and communicate with HR to support compliance.
• Comply with federal, state, and local regulations and company policies and procedures.
• Notify the ADOQ of events that negatively affect product safety, quality, identity, purity, or potency and result in a pause or disruption of business; escalate further to specified quality or regional leaders if necessary.
• Maintain confidentiality of personnel, donor, and center information, and understand applicable hyper-immune program policies and procedures.
• Lead deviation investigations to determine root cause, corrective and preventive actions, and effectiveness checks; monitor CAPAs and checks to ensure issues are resolved.