Director, Study Quality & Compliance — GLP Data Leadership

Novartis; Cambridge (MA); On-site; USD 185,500 - 344,500; Full time

Benefits offered by this job

Health, life and disability coverage

401(k) with company match

Job summary

Novartis in Cambridge, MA, seeks a Senior leader to oversee the Study Quality and Compliance team within Preclinical Safety. Manage data, SOPs and archives while driving a software-based tracking and analytics program for study information.

The role requires GLP experience, leadership, and strong communication skills, with English fluency and a biological science background. Competitive salary and comprehensive benefits are provided.

Qualifications

• Advanced degree or BS with extensive pharmaceutical experience and GLP exposure.
• Experience leading QA/compliance within toxicology or preclinical safety.
• Strong communication and strategic planning skills are required.
• Fluency in English, both written and spoken.

Responsibilities

• Provide strategic oversight to the Study Quality and Compliance team and set long-term goals.
• Lead implementation of tracking and analytics software to enhance quality oversight.
• Oversee toxicology study data management and data warehouse readiness.
• Ensure SEND datasets meet quality and regulatory timelines for submissions.
• Govern SOPs, training records, and interfaces with Archives management.

Skills

Leadership

Communication

GLP knowledge

Project management

Data analytics

Education

Advanced degree in biological-related science

Bachelor’s in biological-related science

Tools

Smartsheet

SEND familiarity

Job description

Novartis in Cambridge, MA, seeks a Senior leader to oversee the Study Quality and Compliance team within Preclinical Safety. Manage data, SOPs and archives while driving a software-based tracking and analytics program for study information.

The role requires GLP experience, leadership, and strong communication skills, with English fluency and a biological science background. Competitive salary and comprehensive benefits are provided.