Aseptic Compliance Lead — Quality & Audits

Kindeva; Bridgeton (MO); On-site; USD 110,000 - 170,000; Full time

Job summary

Kindeva is seeking an Aseptic Compliance Manager to lead the Aseptic Observer Program, ensuring SISPQ and cGMP compliance for sterile injectable filling operations. You will design audits, implement CAPA systems, and drive contamination-control strategies while fostering a culture of quality across Manufacturing and QA teams.

Responsibilities include overseeing audit protocols, training, data-driven metrics reporting, and collaboration with cross-functional leaders to reduce risk and improve

Qualifications

• Bachelor’s degree in science preferred (Microbiology/Biology/Biochemistry/Chemistry/Engineering).
• Minimum 10 years in sterile manufacturing, aseptic processing, and quality assurance in pharma/biotech.
• Strong knowledge of cGMP, FDA/EMA regulations, and contamination control.
• Proficiency with audit methodologies, root cause analysis, and CAPA systems.
• Excellent communication, leadership, and problem-solving skills.

Responsibilities

• Program Design & Oversight: Develop and maintain the Aseptic Observer Program with audit protocols and documentation.
• Quality Systems: Implement and enhance cGMP-aligned quality systems for aseptic filling operations.
• Training & Development: Lead aseptic behavior training and contamination control programs.
• Cross-Functional Collaboration: Coordinate with Manufacturing, Training, and CTS owners on risks and improvements.
• Compliance & Audits: Conduct aseptic filling audits, root cause analyses, and CAPA.
• Process Improvement: Drive initiatives to reduce contamination risk and improve process integrity.
• Culture & Standards: Promote teamwork, quality, and safety in daily operations.
• Metrics & Reporting: Prepare and present aseptic behavior metrics to leadership.

Skills

cGMP knowledge

FDA/EMA regulations

Contamination control

Audit methodologies

CAPA systems

Metrics design

Aseptic gowning

Leadership & communication

Problem solving

Accountability & coaching

Education

Bachelor’s degree in science

Job description

Kindeva is seeking an Aseptic Compliance Manager to lead the Aseptic Observer Program, ensuring SISPQ and cGMP compliance for sterile injectable filling operations. You will design audits, implement CAPA systems, and drive contamination-control strategies while fostering a culture of quality across Manufacturing and QA teams.

Responsibilities include overseeing audit protocols, training, data-driven metrics reporting, and collaboration with cross-functional leaders to reduce risk and improve