Director, Study Quality and Compliance - Nonclinical Safety/Toxicology

About the Role The Director, Study Quality and Compliance leads the PCS Study Quality and Compliance team within the Toxicology line function of Preclinical Safety (PCS). The team handles samples and data for internally and externally conducted toxicology studies, maintains departmental SOPs and training records, and interfaces with Archives to ensure proper storage of toxicology-related materials and records. A major part of this role is to identify and implement a software system enabling effective tracking and analytics of study-related information overseen by this group. What You'll Do

• Lead and provide strategic oversight to the PCS Study Quality and Compliance team, including establishing long-term strategy and yearly goals.
• Modernize group functionality by implementing 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 the internal toxicology study data warehouse.
• Ensure high-quality SEND datasets are ready in a timely manner for regulatory submissions, including SEND datasets from external CROs and de novo generation for internal non-GLP studies.
• Oversee SOPs and training records for PCS personnel to ensure GLP compliance; 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, acquisitions, and licensing deals via oversight and management of study-related data (including SEND). What We're Looking For
• Advanced degree in biological-related sciences with at least 10 years of relevant pharmaceutical experience, or BS with 15 years of experience.
• Experience with GLP guidelines and pharmaceutical toxicology studies, and related quality, compliance, and animal welfare attributes.
• Previous people management or leadership experience.
• Excellent communication, logistical and planning skills.
• Fluency in English (spoken and written). Nice to Have
• Experience with software tools for data and/or program management.
• Experience with SEND, or familiarity with its requirements. Compensation & Benefits
• Salary information not disclosed in posting.