Quality Specialist – Document Controls (Legal, Risk & Compliance)

About the role

The Quality Specialist, Document Controls will manage the full lifecycle of controlled quality documents in a highly regulated clinical‑trial technology environment. You will ensure that SOPs, work instructions, policies, forms and related records are created, reviewed, approved, distributed and retired in strict compliance with GCP, FDA 21 CFR Part 11, EU Annex 11 and ICH guidelines.

Key responsibilities

• Own end‑to‑end document lifecycle management for all controlled quality documents within the QMS.
• Coordinate document reviews, approvals and periodic updates with owners, SMEs and Quality leadership.
• Manage change‑control processes, ensuring justification, approval and communication of all modifications.
• Maintain document numbering, naming conventions and metadata standards.
• Act as system administrator or power user for the electronic Quality Management System.
• Support inspection readiness, audit preparation and continuous improvement of the document‑control framework.

Required profile

• Experience in document control or quality management within a regulated environment.
• Strong knowledge of GCP, FDA 21 CFR Part 11, EU Annex 11 and ICH guidelines.
• Excellent attention to detail and ability to manage multiple concurrent document streams.
• Effective communication skills for interacting with SMEs, document owners and leadership.

Required skills

• Document control processes
• Quality Management System (QMS) administration
• Regulatory compliance (GCP, FDA 21 CFR Part 11, EU Annex 11, ICH)

What we offer

• Opportunity to work in a global, AI‑driven clinical‑research environment.
• Collaboration with leading pharmaceutical companies and CROs.
• Impactful work that accelerates patient access to new therapies.