Note: The job is a remote job and is open to candidates in USA. Astrix is seeking a Biopharma QA & Data Integrity Integration Consultant to provide technical and compliance oversight for preclinical and laboratory asset integrations. The role reviews study reports, validates data transfers, oversees data ingestion, and conducts high-level source data verification to ensure traceability, reconstruction, and adherence to regulatory and ALCOA++ data-integrity principles.
Responsibilities
- Inventory Verification: Review complex preclinical study inventories to identify, log, and prioritize gaps or dependencies across diverse study reports
- Structural Review: Conduct non-scientific, report-level evaluations of Pharmacology, Pharmacokinetic (PK), and Toxicology studies to confirm that all required components, signatures, and appendices are present
- Risk Categorization: Prioritize preclinical data-integrity findings based on their direct relevance and risk to upcoming Health Authority submissions
- Cross-Border Compliance: Navigate and maintain strict compliance regarding potential cross-border data transfers and access restrictions controlled by external deal partners, CROs, or CDMOs
- Third-Party Oversight: Drive quality rigor and timeline adherence even when vendor contracting and direct commercial control remain with an external sponsor and its CRO/CDMO network
- Data Ingestion Management: Supervise the ingestion and organization of data packets arriving from external infrastructures into internal corporate repositories
- ALCOA++ Compliance: Audit records against ALCOA++ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) across paper records, electronic systems, and physical materials like pathology slides
- Data Lifecycle Auditing: Evaluate raw, machine-generated, metadata, processed, audit trail, intermediate, and reported data to map data lineage and ensure reconstruction is possible
- Physical Material Handling: Implement strict protocols for logging, cataloging, storing, and tracking the chain-of-custody for physical records, paper scans, and pathology slides during physical transfers
Skills
- Proven experience providing hands-on Quality Assurance (QA) and technical review of preclinical and laboratory data rather than generic project management
- Deep familiarity with Health Authority submission processes ( IND, CTA, CTN ) and GxP regulatory expectations
- Demonstrated ability to bridge the gap between traditional paper records and modern electronic laboratory systems (e.g., LIMS, ELN)
- Track record of operating under strict confidentiality mandates with clean conflict-of-interest screening across major CROs, CDMOs, and external deal partners
- Must be US-based
- Ability to work ~95% remotely , while remaining available to travel to site locations as needed for IT hardware support or physical data reviews
Benefits
- ~95% remote work flexibility
- Client-provided accounts, laptops, and internal software systems
Company Overview