Strategic Director, GMP Quality & Ops

BioSpace; Waltham (MA); On-site; USD 188,000 - 230,000; Full time

Job summary

A biotechnology firm based in Waltham, MA is seeking a Director of QA GMP Operations responsible for managing quality in external manufacturing and overseeing GMP activities. The ideal candidate will have at least 10 years of experience in GMP operations, demonstrating strong leadership skills and the ability to collaborate across teams. The position offers a competitive salary range of $188,000 to $230,000 USD, ensuring compliance and operational excellence in a dynamic environment.

Qualifications

• Minimum of 10+ years of experience in GMP Quality Operations in biotech.
• Leadership experience managing cross-functional teams.
• Strong collaboration skills to interact with stakeholders.

Responsibilities

• Manage external quality operations for GMP manufacturing.
• Oversee deviations and investigations adhering to cGMP principles.
• Collaborate to ensure compliance at CDMOs and within internal operations.

Skills

GMP Quality Operations

Leadership

Cross-functional collaboration

Project management

Excellent communication skills

Education

BA/BS degree

Job description

A biotechnology firm based in Waltham, MA is seeking a Director of QA GMP Operations responsible for managing quality in external manufacturing and overseeing GMP activities. The ideal candidate will have at least 10 years of experience in GMP operations, demonstrating strong leadership skills and the ability to collaborate across teams. The position offers a competitive salary range of $188,000 to $230,000 USD, ensuring compliance and operational excellence in a dynamic environment.