Director, Study Quality & Compliance — Toxicology Data Leader

Novartis Group Companies; Cambridge (MA); Hybrid; USD 185,500 - 344,500; Full time

Job summary

Novartis Group of Companies in Cambridge, MA seeks a Director to oversee the Study Quality and Compliance team within Preclinical Safety. You will drive GLP compliance, manage data for internal and external toxicology studies, and implement software to track study information and analytics.

The role requires an advanced biology degree with extensive pharma experience or a BS with substantial background, leadership skills, and fluency in English.

Qualifications

• Advanced degree or extensive experience in pharmaceutical biology and toxicology.
• Experience working with GLP guidelines and toxicology studies.
• Experience leading teams and projects.
• Excellent written and spoken English communication.
• Strong leadership and organizational abilities.

Responsibilities

• Oversee the Study Quality and Compliance team and set long‑term strategy.
• Lead implementation of tracking and analytics software across the toxicology function.
• Manage toxicology study data and prepare data warehouse availability.
• Ensure SEND datasets are high quality and regulatory-ready.
• Oversee SOPs and training records for GLP compliance and archives interfacing.
• Support biomarker data transfer and diligence activities involving SEND data.

Skills

Animal Models

Bioinformatics

Collaboration

Communication Skills

Data Analysis

Decision Making

Ethics

Leadership

Management

Mentorship

Problem Solving

Regulatory Compliance

Researching

Risk Assessments

Toxicology

Education

Advanced degree in biological-related sciences

BS degree in biological-related sciences

Job description

Novartis Group of Companies in Cambridge, MA seeks a Director to oversee the Study Quality and Compliance team within Preclinical Safety. You will drive GLP compliance, manage data for internal and external toxicology studies, and implement software to track study information and analytics.

The role requires an advanced biology degree with extensive pharma experience or a BS with substantial background, leadership skills, and fluency in English.