Overview In this role you will provide scientific and operational support to the Study Quality and Compliance group within Toxicology (Preclinical Safety). You will ensure training records, CVs and job descriptions are maintained, and that SOPs are reviewed and kept up to date, supporting inspections and internal audits. You will coordinate archives transfers for GLP/non-GLP study materials and assist with SEND dataset creation and QC for FDA submissions. You will contribute to tracking study-related information and work across multiple initiatives to uphold compliance and data integrity.
Compensation / Benefits- comprehensive benefits package
- 401(k) with company contribution and match
- performance-based cash incentive
- eligibility for annual equity awards
- generous time off package (vacation, personal days, holidays)
Responsibilities- Oversee periodic review and maintenance of PCS SOPs with stakeholder input and cross-reference to company SOPs
- Ensure PCS compliance with training records, CVs, and JDs in line with GLP requirements
- Support Archives Records Management (ARM) by listing studies with archived records and coordinating transfers to permanent locations
- Support SEND package creation and quality review for FDA submissions
- Assist the Study Quality and Compliance team in tracking study-related information across multiple workstreams
Key requirements- Degree in biological related sciences
- 8+ years of relevant pharmaceutical experience
- Experience in GLP settings and regulatory compliance related to toxicology studies
- Strong communication and excellent logistical/planning skills
- Fluent in English (spoken and written)
- Desirable: experience with SEND packages
- Desirable: experience with software for online information and program management
- communication skills
- logistical/planning skills
- attention to detail
- SEND package creation and QC
- GLP regulatory compliance
- Archives Records Management (ARM)
