Sterile QA Product Manager: Tech Transfer & Compliance

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

Job summary

Shionogi Inc. is seeking a QA Product Manager for Sterile Products in Florham Park, NJ. This critical role ensures the quality, safety, and compliance of sterile pharmaceutical products with responsibilities including overseeing validation activities, leading technology transfer projects, and conducting audits of third-party manufacturers. The ideal candidate has a Bachelor's degree in Life Sciences, at least five years in pharmaceutical Quality Assurance, and experience with sterile products. Competitive salary range is $120,000 - $150,000, with comprehensive benefits and some travel required.

Qualifications

• Minimum of five years of experience in pharmaceutical Quality Assurance.
• Experience leading or supporting technology transfer activities.
• Strong understanding of sterile manufacturing processes.

Responsibilities

• Lead technology transfer projects for drug substance and product.
• Oversee validation activities for sterile manufacturing processes.
• Conduct audits of third-party manufacturers.

Skills

Pharmaceutical Quality Assurance

Sterile manufacturing processes

Technology transfer activities

Project management

Audit experience

Quality management systems

Microsoft Office proficiency

Education

Bachelor's degree in Life Sciences

Tools

Veeva

Job description

Shionogi Inc. is seeking a QA Product Manager for Sterile Products in Florham Park, NJ. This critical role ensures the quality, safety, and compliance of sterile pharmaceutical products with responsibilities including overseeing validation activities, leading technology transfer projects, and conducting audits of third-party manufacturers. The ideal candidate has a Bachelor's degree in Life Sciences, at least five years in pharmaceutical Quality Assurance, and experience with sterile products. Competitive salary range is $120,000 - $150,000, with comprehensive benefits and some travel required.