Sterility Assurance Lead

Preferred Home Health Care & Nursing Services; Bradley (IL); On-site; USD 180,000 - 240,000; Full time

Job summary

Unknown Company seeks a Global Sterility Assurance Systems & Standards Lead to establish and govern sterility programs across a worldwide biotech manufacturing network.

You will define sterility standards, policies, and quality systems in line with cGMP, FDA, and EU requirements, oversee aseptic processing controls, contamination prevention, and validation processes, and mentor teams. This role provides global leadership and supports inspections and continuous improvement initiatives.

Qualifications

• Experience leading sterility programs across a global biotech network.
• Expertise in defining and maintaining sterility standards and quality systems.
• Ability to ensure compliance with cGMP, FDA, and EU regulations.

Responsibilities

• Define and maintain sterility standards, policies, and quality systems.
• Oversee aseptic processing controls and contamination prevention strategies.
• Drive global leadership, inspections, audits, and continuous improvement.
• Mentor teams to ensure safe, compliant therapies for patients.

Skills

Sterility program governance

Aseptic processing controls

Regulatory compliance

Global leadership

Audits & inspections

Continuous improvement

Job description

Global Sterility Assurance Systems & Standards Lead is responsible for establishing and governing top-tier sterility programs across a global biotech manufacturing network.

Key duties include defining and maintaining sterility standards, policies, and quality systems in compliance with cGMP, EU, and FDA regulations.

They oversee aseptic processing controls, contamination prevention strategies, and validation processes, working closely with sites to harmonize procedures and address gaps.

The role involves providing global leadership, supporting inspections and audits, driving continuous improvement, and mentoring teams to ensure the delivery of safe, compliant therapies for patients worldwide.