Director, Study Quality and Compliance - Nonclinical Safety/Toxicology

Job Description Summary Location: Cambridge MA; Internal: Director; LI#-Hybrid. This role oversees the Study Quality and Compliance team within the Toxicology line function of Preclinical Safety (PCS). The team handles samples and data associated with both internally and externally conducted toxicology studies; maintains departmental SOPs; oversees training records; and interfaces with the archives function to ensure proper storage of toxicology-related materials and records. A major part of this role will be to identify and implement a software system that enables effective tracking and analytics of study‑related information overseen by this group. Key Responsibilities Lead and provide strategic oversight to the PCS Study Quality and Compliance team including responsibility for establishing long‑term strategy and yearly goals which support it. Modernize the group functionality leading the implementation of tracking, management, and data analytics software (e.g., Smartsheet) across the toxicology line function to enhance quality and compliance oversight of toxicology studies. Oversee toxicology study data management from external and internal studies; ensure data suitability and availability for our internal toxicology study data warehouse. Ensure SEND (Standard for Exchange of Nonclinical Data) datasets are of high quality and ready in a timely manner for regulatory submissions, including datasets from external CROs and de‑novo generation for internal non‑GLP studies. Oversee SOPs and training records for PCS personnel to ensure compliance with GLP expectations, and serve as the management interface with the Archive Records Management team. Oversee support for biomarker and pathology with respect to shipment of study samples and data transfer of digital slides. Support diligence acquisition and licensing deals through oversight and management of study‑related data (including SEND) that need to be transferred. Essential Requirements Advanced degree in biological‑related sciences with at least 10 years of relevant pharmaceutical experience, or BS degree in biological‑related science with 15 years of experience. Previous experience working with GLP guidelines and pharmaceutical toxicology studies, and associated quality, compliance, and animal welfare attributes. Previous people management or leadership experience. Good communication skills, and excellent logistical/planning skills. Fluent in English (spoken and written). Desirable Requirements Previous experience with software tools for data and/or program management is highly desired. Previous experience with SEND, or at a minimum good general familiarity with its requirements is desired. Salary Range 185,500 – 344,500 per year. Benefits The final salary offered is determined based on relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance‑based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US‑based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time‑off package including vacation, personal days, holidays and other leaves. Skills Desired Animal Models Bioinformatics Collaboration Communication Skills Data Analysis Decision Making Ethics Laboratory Leadership Management Mentorship Problem Solving Regulatory Compliance Researching Risk Assessments Toxicology Training Waterfall Model EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e‑mail to View email address on click.appcast.io or call View phone number on click.appcast.io and let us know the nature of your request and your contact information. Please include the job requisition number in your message. #J-18808-Ljbffr Healthcare Businesswomen’s Association