Manufacturing Quality Oversight Professional

About the Role

In this exciting position, you will be responsible for ensuring the quality and integrity of Takeda's manufacturing processes. As a Regulatory Compliance Expert II, you will work closely with our quality assurance team to identify and mitigate potential risks associated with our products.

This role requires a strong understanding of FDA regulations and GMPs, as well as excellent communication and interpersonal skills. If you are a detail-oriented professional with a passion for quality assurance, we encourage you to apply.

Key Responsibilities

• Conduct regular audits and inspections of manufacturing facilities to ensure compliance with regulatory requirements.
• Develop and implement corrective and preventive actions (CAPAs) to address identified risks and nonconformities.
• Collaborate with cross-functional teams to revise and improve standard operating procedures (SOPs).
• Provide training and coaching to local employees on quality procedures and best practices.
• Contribute to the development and implementation of quality metrics and KPIs.