Sterile QA Product Manager | Tech Transfer & Compliance

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

Job summary

Shionogi Inc. in Florham Park, NJ, seeks a QA Product Manager (Sterile Products) to ensure quality, safety, and regulatory compliance of sterile products manufactured by CMOs.

You will drive tech transfer, validation, batch disposition, audits, and CAPAs across the product lifecycle, partnering with global teams to uphold regulatory expectations. The role requires 5+ years in pharmaceutical QA with a focus on sterile products, and strong cross-functional collaboration.

Qualifications

• Bachelor's degree in Life Sciences; advanced degree desirable.
• Minimum of five years in pharmaceutical QA focusing on sterile products and third-party manufacturing.
• Experience leading technology transfer activities across various equipment types.
• Experience with audits and QA activities for CMOs/CDMOs in sterile production.
• Proficiency with MS Office; strong regulatory and technical communication.

Responsibilities

• Lead end-to-end technology transfer projects for drug substance/product with R&D, manufacturing, and external partners.
• Oversee validation activities for sterile manufacturing processes and sterilization validation.
• Manage QA activities for sterile products at CMOs/CDMOs, including deviations, investigations, and CAPAs.
• Conduct audits of third-party manufacturers to ensure quality and regulatory compliance.
• Collaborate with Regulatory Affairs on registrations, submissions, and inspections.
• Assist in drafting Quality Agreements, Annual Product Reviews, and Stability Protocols.

Skills

Project management

Quality systems

Cross-functional collaboration

Regulatory communication

Education

Bachelor's degree in Life Sciences

Tools

Veeva

Microsoft Office

Job description

Shionogi Inc. in Florham Park, NJ, seeks a QA Product Manager (Sterile Products) to ensure quality, safety, and regulatory compliance of sterile products manufactured by CMOs.

You will drive tech transfer, validation, batch disposition, audits, and CAPAs across the product lifecycle, partnering with global teams to uphold regulatory expectations. The role requires 5+ years in pharmaceutical QA with a focus on sterile products, and strong cross-functional collaboration.