Global Lead, Contamination Control & Sterility Assurance

Cytiva; Westborough (MA); Presencial; USD 110 000 - 125 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Bonus eligible

401(k) plan

Health insurance

Paid time off

Resumo da oferta

Cytiva is seeking a Senior Manager for Contamination Control & Sterility Assurance to lead cross-site contamination control and sterility programs, ensuring quality, regulatory readiness and patient safety. The role reports to Global QARA and supports the Filtration Business Unit across Cytiva manufacturing sites in the US.

Ideal candidates have 10+ years in regulated life sciences, deep expertise in contamination control and sterility, and a track record of regulatory inspections, CAPA, and

Qualificações

• Bachelor’s degree (or higher) in a scientific discipline related to pharma/biotech.
• 10+ years of experience in regulated life sciences manufacturing environments.
• Expertise in contamination control, sterility assurance, aseptic processing and environmental monitoring.
• Experience supporting regulatory inspections, audits, investigations, CAPA and risk management.

Responsabilidades

• Lead contamination control and sterility assurance programs across multiple sites.
• Drive continuous improvement of contamination control strategies and environmental monitoring.
• Serve as SME for contamination control, sterility, microbial control, sterilization and related practices.
• Provide leadership during regulatory inspections, audits, and internal quality assessments.
• Lead investigations, root cause analysis, risk assessments and CAPA activities.
• Establish metrics and drive performance across the network.

Conhecimentos

Contamination control

Sterility assurance

Aseptic processing

Environmental monitoring

Regulatory inspections

CAPA

Quality systems

Cross-functional leadership

Global multi-site

Formação académica

Bachelor's degree in Microbiology/Biology/Pharmaceutical Sciences/Engineering

Master's degree in Microbiology/Biology/Pharmaceutical Sciences/Engineering

Descrição da oferta de emprego

Cytiva is seeking a Senior Manager for Contamination Control & Sterility Assurance to lead cross-site contamination control and sterility programs, ensuring quality, regulatory readiness and patient safety. The role reports to Global QARA and supports the Filtration Business Unit across Cytiva manufacturing sites in the US.

Ideal candidates have 10+ years in regulated life sciences, deep expertise in contamination control and sterility, and a track record of regulatory inspections, CAPA, and