Documentation Manager

Responsibilities

• Support product and operational execution in a regulated software environment, ensuring tasks, approvals, and follow-ups are tracked and completed on time
• Manage controlled documentation including SOPs, policies, templates, and training records
• Route documents for review and approval and maintain version control and document repositories
• Track training assignments, completion records, and required documentation for compliance purposes
• Support audit readiness activities and preparation of compliance evidence
• Track operational workstreams, decisions, timelines, and action items across cross-functional teams
• Coordinate follow-ups with product, engineering, QA, and leadership to ensure alignment and closure
• Work effectively with globally distributed teams across time zones

Requirements

• Strong hands-on experience in documentation management and process follow-up
• Solid familiarity with compliance requirements in regulated industries such as pharma, biotech, medical devices, or clinical research
• Experience supporting QMS, audits, or regulatory frameworks (e.g. FDA, GxP, ISO)
• Fluent English communication skills, both written and spoken
• Experience using tools such as Google Workspace, Confluence, Jira, and electronic approval systems
• Highly organized, detail-oriented, and comfortable managing multiple parallel responsibilities
• Able to work independently and coordinate across teams and regions