Employment Type
Permanent full-time
Working arrangement
Working across standard business hours | Hybrid
About the Role
Our client is a technology company specialising in the development of AI-enabled workflow platforms for use within laboratory, pharmaceutical, biotechnology and healthcare environments. The Head of QA & Regulatory Affairs will play an integral role in shaping a next-generation AI-enabled workflow platform designed for regulated environments. This is a rare opportunity to join at ground level and directly influence how regulated AI workflows are designed, governed, validated and deployed within GxP environments. Working closely with founders, product, engineering and early customers, you will help design compliant, inspection-defensible workflows covering areas such as:
* Audit management
* Deviations
* CAPA
* Validation reporting
* Supplier quality
* Inspection readiness
This role sits at the intersection of:
* Regulated SaaS platforms
* Life sciences compliance
* Digital quality transformation
* AI-assisted workflow automation
* Validation and inspection readiness
Key Responsibilities
* Review product concepts and identify compliance risks
* Define regulated workflow control models
* Develop workflow examples including deviations, CAPA, audit reports and validation summaries
* Define audit trail and decision log requirements
* Help shape approval, review and e-signature workflows
* Define validation package structures and compliance documentation
* Support early customer discovery conversations with QA, validation and compliance teams
* Identify gaps across Part 11, Annex 11 and data integrity expectations
Required Experience
* Strong working knowledge across GMP, GCP, GLP and GDP environments
* Experience with CAPA, deviations and non-conformance workflows
* Experience with QMS workflow design, CSV, CSA and GAMP 5
* Strong understanding of data integrity, ALCOA+, 21 CFR Part 11 and EU GMP Annex 11
* Experience with validation lifecycle documentation
* Audit management and inspection readiness experience
* Experience working with validated SaaS platforms, LIMS, eTMF, digital quality systems and regulated workflow platforms
Exposure to platforms such as Veeva Vault, TrackWise, MasterControl, ETQ, LabWare or STARLIMS will be highly regarded.
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