Senior Manager

Position

The Senior Manager, Quality Assurance will have a strong focus on GMP, ensuring compliance with industry regulations while fostering a collaborative, cross-functional environment. Reporting to the Sr. Director, Quality Assurance this individual will play a critical role in developing and maintaining quality systems, driving excellence across all GMP activities.

About You

You are a GMP professional with expertise in the development and launch of GMP operational systems and processes. You appreciate rules that govern activities. You appreciate consistency.

What You’ll Do

• Assist with the development and implementation of GMP quality systems in accordance with ICH, FDA, EMA, global regulations and industry guidance.
• Review all documents/reports especially as they relate to method development, validation activities and other analytical activities.
• Provide compliance oversight for internal and contracted external GMP activities.
• Coordinate and/or perform virtual or on-site audits as needed.
• Provide quality oversight for GMP CDMOs (including quality agreements) and manage GMP product batch record review and disposition.
• Assist with the development, im...