Sterility Assurance Lead

Black Women's Mental Health Institute; Bradley (IL); On-site; USD 150,000 - 190,000; Full time

Job summary

Black Women's Mental Health Institute is seeking a Global Sterility Assurance Systems & Standards Lead to define and oversee sterility programs across a worldwide biotech manufacturing network. You will establish standards, lead cross-functional teams, and drive regulatory compliance with cGMP, FDA and EU requirements.

You will mentor global teams, support inspections, and push continuous improvement in sterility assurance to safeguard patient therapies.

Qualifications

• Experience in sterile manufacturing and contamination control.
• Proven knowledge of cGMP, FDA, and EU regulations.
• Strong leadership for global teams.
• Excellent collaboration and problem-solving skills.

Responsibilities

• Define and maintain sterility standards, policies, and quality systems.
• Oversee aseptic processing controls and validation for sterile products.
• Collaborate with manufacturing sites to harmonize procedures.
• Provide global leadership in sterility assurance and support audits.
• Mentor teams to ensure safety and quality for patient therapies.

Skills

Sterile manufacturing

Contamination control

Validation processes

cGMP compliance

FDA regulations

EU regulations

Leadership

Collaboration & communication

Job description

Role Overview

The

Role Overview

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

Key Responsibilities

• Define and maintain sterility standards, policies, and quality systems compliant with cGMP, EU, and FDA regulations.
• Oversee aseptic processing controls, contamination prevention strategies, and validation processes for sterile products.
• Collaborate with manufacturing sites to harmonize procedures and address compliance gaps.
• Provide global leadership in sterility assurance, support inspections and audits, and drive continuous improvement initiatives.
• Mentor teams to ensure adherence to safety and quality standards for patient therapies.

Qualifications & Skills

• Expertise in sterile manufacturing, contamination control, and validation processes.
• Strong knowledge of cGMP, EU, and FDA regulations.
• Leadership skills to guide and support global teams and initiatives.
• Excellent collaboration, communication, and problem-solving abilities.