The hiring gap in regulated Indian laboratories
Regulated roles in Indian laboratories — Study Directors, Quality Assurance leads, Test Facility Managers, Principal Investigators — carry responsibilities that extend well beyond technical competence. These roles are named in regulatory frameworks, cited in inspection reports, and personally accountable for data integrity, study validity, and compliance outcomes. Yet most laboratories hire for these positions using the same unstructured interview processes they use for bench scientists.
The result is a persistent quality gap: technically competent scientists placed in regulatory roles they are not equipped to fulfil. The consequences surface during inspections, when the capabilities of named personnel are directly assessed by regulatory authorities.
What regulators expect from named personnel
Under OECD GLP, the Study Director has unrestricted responsibility for the overall conduct of the study and the final report. The Test Facility Manager ensures that qualified personnel, appropriate resources, and adequate facilities are available. QA personnel must be independent, technically competent, and authorised to halt studies when critical deviations occur. Regulators assess not just whether these roles are filled, but whether the individuals in them demonstrate the competence and authority the framework requires.
The technical evaluation panel approach
A technical evaluation panel is a structured hiring process specifically designed for regulated roles. It combines: scenario-based assessment (how would you handle a critical deviation during an ongoing study?), technical knowledge verification (OECD principles, data integrity, study lifecycle management), regulatory awareness testing (inspection readiness, authority expectations), and leadership evaluation (ability to make compliance decisions under commercial pressure).
Implementation
Building a technical evaluation panel requires: defining role-specific competency frameworks tied to regulatory requirements, developing scenario banks that reflect real operational challenges, training assessors (typically senior QA and operations leaders) on structured evaluation, and calibrating scoring to distinguish between candidates who know the regulations and candidates who can apply them under pressure.
LaborWissen designs and facilitates technical evaluation panels for laboratories and CROs hiring for regulated roles. We also provide leadership capability assessments for organisations evaluating their existing Study Directors, QA leads, and TFMs against regulatory expectations.