Global Lead, Contamination Control & Sterility

Regulatory Jobs

United States

Remote

USD 110,000 - 125,000

Full time

8 days ago

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Job summary

Cytiva, a Danaher operating company, seeks a Senior Manager for Contamination Control & Sterility Assurance to lead cross-site programs ensuring regulatory compliance and quality excellence. You will direct contamination control strategies, microbial control, environmental monitoring, and aseptic processing across multiple manufacturing sites.

The role reports to Global QARA and is an on-site position with travel. 110k–125k USD salary plus bonus eligibility, with comprehensive benefits.

Qualifications

Bachelor's degree or higher in a related scientific discipline.
10+ years of experience in regulated life sciences manufacturing environments.
Expertise in contamination control, sterility assurance, aseptic processing, and microbial control programs.

Responsibilities

Lead contamination control and sterility assurance programs across multiple manufacturing sites.
Drive continuous improvement of contamination control strategies and environmental monitoring.
Serve as SME for contamination control, sterility assurance, microbial control, sterilization, and aseptic processing.
Provide technical leadership during regulatory inspections, customer audits, and internal quality assessments.
Lead investigations, root cause analysis, CAPA activities related to contamination events and sterility issues.
Set and monitor metrics to drive performance and standardization across sites.