Hiring: Aseptic Compliance Manager Company: Kindeva Drug Delivery Location: St. Louis County, MO Job Posted Time: 2026-09-16 14:46:15 Target Skills & Keywords : Embedded Systems, Quality Assurance, Root Cause Analysis About the job Experience: •Minimum of 10 years previous experience in sterile manufacturing, aseptic processing and quality assurance in a pharmaceutical/biotech environment. Required Skills: •Program Design & Oversight: Develop and maintain the Aseptic Observer Program, including audit protocols, checklists, and documentation requirements •Quality Systems: Implement and enhance quality systems to support aseptic filling operations, ensuring alignment with cGMP and regulatory standards •Training & Development: Lead and improve the aseptic behavior training program, incorporating industry best practices and contamination control strategies. •Cross-Functional Collaboration: Partner with Manufacturing leadership, training leadership, and the Contamination Control Strategy owners to address quality risks and process improvements. •Compliance & Audits: Conduct and review aseptic filling audits, root cause analyses, and corrective/preventive actions (CAPA) •Process Improvement: Drive continuous improvement initiatives to enhance efficiency, reduce contamination risk, and ensure product integrity •Culture & Standards: Foster a culture of teamwork, productivity, and quality excellence, ensuring SISPQ is embedded in daily operations. •Metrics & Reporting: Prepare and present aseptic behavior metrics to leadership. Qualifications: •Bachelor’s degree in science preferred (Microbiology, Biology, Biochemistry, Chemistry, Engineering, Pharmacy, or related science) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!