Aseptic Compliance Manager

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Aseptic Compliance Manager is a key member of the Quality Assurance Team, responsible for designing, implementing, and continuously improving the Aseptic Observer Program. This program ensures quality oversight of sterile injectable filling operations, supporting compliance with regulatory requirements and maintaining the highest standards of safety, identity, strength, purity, and quality (SISPQ). Role Summary The Aseptic Compliance Manager is a key member of the Quality Assurance Team, responsible for designing, implementing, and continuously improving the Aseptic Observer Program. This program ensures quality oversight of sterile injectable filling operations, supporting compliance with regulatory requirements and maintaining the highest standards of safety, identity, strength, purity, and quality (SISPQ). Role Responsibilities 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. Education BASIC QUALIFICATIONS Bachelor’s degree in science preferred (Microbiology, Biology, Biochemistry, Chemistry, Engineering, Pharmacy, or related science) Experience Minimum of 10 years previous experience in sterile manufacturing, aseptic processing and quality assurance in a pharmaceutical/biotech environment. Technical Skills Strong knowledge of cGMP, FDA/EMA regulations, and contamination control strategies.Proficiency in audit methodologies, root cause analysis, and CAPA systems. Proficiency in metrics design and presentation. The capability to aseptically gown and maintain various levels of certification to enter and support the manufacturing areas. The capability to focus attention on colleagues’ behaviors that in turn leads to higher-than-normal performance. Ability to hold self and others accountable and to encourage colleagues to take personal responsibility for their performance / actions. Ability to coach by providing constructive feedback combined with a willingness to develop and listen to colleague ideas. Demonstrated aptitude to execute aseptic techniques to a high degree of proficiency. Must be able to communicate, present, and work well with all facility departments. Promote a positive team environment while performing all tasks in a safe manner. Excellent communication, leadership, and problem-solving skills. Job duties involve occasional lifting (less than 35 lbs.), reaching, and sitting while working at computer terminal. California residents should review our Notice for California Employees and Applicants before applying. Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral. Equal Opportunity Employer Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Do you see yourself as part of the Kindeva mission? Click Apply Now Today!