QA & Data Integrity Integration Consultant

Astrix; Town of Texas (WI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Remote work flexibility

Occasional site travel

Job summary

Astrix is seeking a Biopharma QA & Data Integrity Integration Consultant to oversee preclinical data workflows and data transfer validation. This role focuses on report-level completeness reviews, ALCOA++ compliance, and SDV practices to ensure traceable data reconstruction without scientific evaluation.

The ideal candidate has deep knowledge of Health Authority submissions (IND, CTA, CTN) and experience bridging paper records with modern systems (LIMS/ELN), while maintaining strict

Qualifications

• Hands-on QA experience reviewing preclinical and laboratory data.
• Deep familiarity with Health Authority submission processes (IND, CTA, CTN).
• Bridge between paper records and electronic lab systems (LIMS/ELN).
• Strict confidentiality with CROs/CDMOs and external partners.

Responsibilities

• Study Report & Data Completeness Review: verify inventories, structural components, and signatures.
• Data Transfer from Third Parties: ensure cross-border compliance and data ingestion controls.
• ALCOA++ Compliance: audit records across paper and electronic systems for traceability.
• Data Lifecycle Auditing: map data lineage from raw to reported data.

Skills

Hands-on QA Experience

Regulatory Mastery

Hybrid Data Review

Security & Confidentiality

Tools

LIMS

ELN

Job description

The Biopharma QA & Data Integrity Integration Consultant plays a pivotal role in the technical and compliance oversight of preclinical and laboratory asset integrations resulting from corporate acquisitions or in-licensing agreements. This specialized role focuses strictly on report-level data completeness reviews, data transfer validation, and high-level Source Data Verification (SDV) to guarantee data traceability and reconstruction without stepping into scientific or technical evaluation.

The ideal candidate possesses deep expertise in the laboratory data lifecycle, Health Authority submission foundations (IND, CTA, CTN), regulatory expectations, and strict adherence to Data Integrity principles and ALCOA++.

Study Report & Data Completeness Review

• 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.

Data Transfer from Third Parties

• 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.

Technical & Professional Requirements

Minimum Qualifications:

• Hands-on QA Experience: Proven experience providing hands-on Quality Assurance (QA) and technical review of preclinical and laboratory data rather than generic project management.
• Regulatory Mastery: Deep familiarity with Health Authority submission processes (IND, CTA, CTN) and GxP regulatory expectations.
• Hybrid Data Review: Demonstrated ability to bridge the gap between traditional paper records and modern electronic laboratory systems (e.g., LIMS, ELN).
• Security & Confidentiality: Track record of operating under strict confidentiality mandates with clean conflict-of-interest screening across major CROs, CDMOs, and external deal partners.

Logistics & Infrastructure Constraints:

• Location: Must be US-based.
• Remote Flexibility: Ability to work ~95% remotely, while remaining available to travel to site locations as needed for IT hardware support or physical data reviews.
• Environment: Fully operational using client-provided accounts, laptops, and internal software systems.