Aseptic Compliance Lead – Quality and GMP Excellence

Kindeva Drug Delivery; Missouri; On-site; USD 140,000 - 190,000; Full time

Job summary

Kindeva Drug Delivery is seeking an Aseptic Compliance Manager to lead the Aseptic Observer Program, ensuring sterile filling operations meet cGMP, regulatory requirements, and SISPQ standards across the site.

You will design, implement, and continuously improve quality systems, audit processes, CAPAs, and contamination control strategies, while coaching teams and partnering with Manufacturing, QA, and Training to elevate aseptic performance.

Qualifications

• Bachelor’s degree in science (Microbiology, Biology, Biochemistry, Chemistry, Engineering, Pharmacy) preferred.
• Minimum 10 years’ experience in sterile manufacturing, aseptic processing, and quality assurance in pharma/biotech environments.
• Demonstrated aptitude to execute aseptic techniques and lead quality improvement initiatives.

Responsibilities

• Design and maintain the Aseptic Observer Program with audit protocols and documentation.
• Implement and enhance quality systems supporting aseptic filling operations.
• Lead aseptic behavior training and contamination control strategies.
• Collaborate with Manufacturing, Training leadership, and Contamination Control Strategy owners.
• Conduct aseptic filling audits, root cause analyses, and CAPAs.
• Drive continuous improvement to reduce contamination risk and protect product integrity.
• Embed SISPQ in daily operations and foster a culture of quality.
• Prepare and present aseptic behavior metrics to leadership.

Skills

cGMP knowledge

Regulatory compliance

Audit methodologies

CAPA systems

Leadership

Contamination control

Root cause analysis

Training design

Cross-functional collaboration

Education

Bachelor’s degree in science

Job description

Kindeva Drug Delivery is seeking an Aseptic Compliance Manager to lead the Aseptic Observer Program, ensuring sterile filling operations meet cGMP, regulatory requirements, and SISPQ standards across the site.

You will design, implement, and continuously improve quality systems, audit processes, CAPAs, and contamination control strategies, while coaching teams and partnering with Manufacturing, QA, and Training to elevate aseptic performance.