QA Product Manager, Sterile Products & Tech Transfer

Shionogi Inc. (U.S.); Florham Park (NJ); On-site; USD 120,000 - 150,000; Full time

Job summary

Shionogi Inc. (U.S.) is seeking a QA Product Manager (Sterile Products) to ensure quality, safety, and regulatory compliance for sterile products manufactured by CMOs. You will drive technology transfer, validation, batch disposition, audits, and CAPAs across the product lifecycle.

The role collaborates with global teams, supports regulatory inspections, and drafts Quality and Technical Agreements. Travel up to 40% domestically and internationally may be required.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum 5 years in pharmaceutical QA with sterile products/CMO experience.
• Experience leading technology transfer across equipment types.
• Strong knowledge of sterile manufacturing and validation requirements.
• Experience auditing CMOs/CDMOs in a cGMP environment.

Responsibilities

• Lead end-to-end technology transfer projects for sterile products with internal and external partners.
• Oversee validation activities for sterile manufacturing processes including sterilization.
• Guide QA activities for sterile products including deviations, CAPAs, and batch disposition.
• Conduct audits of third-party manufacturers to ensure quality standards.
• Support regulatory submissions and inspections with Regulatory Affairs.

Skills

Project management

Cross-functional

Attention to detail

Risk-based decisions

Communication

Education

Bachelor's degree in Life Sciences

Advanced degree desirable

Tools

Veeva

Microsoft Office

Job description

Shionogi Inc. (U.S.) is seeking a QA Product Manager (Sterile Products) to ensure quality, safety, and regulatory compliance for sterile products manufactured by CMOs. You will drive technology transfer, validation, batch disposition, audits, and CAPAs across the product lifecycle.

The role collaborates with global teams, supports regulatory inspections, and drafts Quality and Technical Agreements. Travel up to 40% domestically and internationally may be required.