Director, Study Quality and Compliance - Nonclinical Safety/Toxicology

Novartis•Cambridge, MA

1d•$185,500 - $344,500•Hybrid

About The Position

The Director, Study Quality and Compliance oversees the Study Quality and Compliance team within the Toxicology line function of PCS. The team handles samples and data from internally and externally conducted toxicology studies, maintains departmental SOPs, oversees training records, and interfaces with Archives to ensure proper storage of toxicology-related materials and records. A key focus is identifying and implementing software for effective tracking and analytics of study-related information. The role provides strategic leadership, establishes long-term strategy and yearly goals, and modernizes team functionality through implementation of tracking, management, and data analytics software across the toxicology line function. It oversees toxicology study data management, including suitability and availability for the internal toxicology study data warehouse, and ensures high-quality SEND datasets are available promptly for regulatory submissions. The position also oversees SOPs, training records, archive coordination, biomarker and pathology sample shipments and digital-slide data transfer, and study-related data transfers supporting diligence, acquisition, and licensing deals.

Requirements

Advanced degree in a biological-related science and at least 10 years of relevant pharmaceutical experience; or a BS degree in a biological-related science and at least 15 years of experience; or 25 or more years of relevant industry experience overseeing and ensuring compliance of toxicology studies.
Previous experience working with GLP guidelines and pharmaceutical toxicology studies, including associated quality, compliance, and animal welfare attributes.
Good communication skills.
Excellent logistical and planning skills.
Fluent in spoken and written English.

Nice To Haves

Previous experience with software tools for data and/or program management is highly desired.
Previous experience with SEND, or at minimum good general familiarity with its requirements, is desired.

Responsibilities

Lead and provide strategic oversight to the PCS Study Quality and Compliance team, establishing long-term strategy and yearly goals.
Lead implementation of tracking, management, and data analytics software across the toxicology line function to enhance quality and compliance oversight.
Oversee toxicology study data management for internal and external studies, including data suitability and availability for the internal toxicology study data warehouse.
Ensure SEND datasets are 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 PCS personnel SOPs and training records to ensure compliance with GLP expectations, and serve as the management interface with the Archive Records Management team.
Oversee support for biomarker and pathology activities, including shipment of study samples and transfer of digital-slide data.
Support diligence, acquisition, and licensing deals through oversight and management of study-related data, including SEND, that must be transferred.