Technical Writer - Pharma IT Compliance

Position Summary -

The Technical Writer will be responsible for developing, maintaining, and improving IT process documentation within a regulated pharmaceutical (GxP) environment. This role involves authoring and managing key compliance documents, supporting infrastructure qualification activities, and ensuring alignment with global IT standards and QA expectations. The individual will work closely with project teams, IT compliance, and global shared services to ensure adherence to regulatory requirements and company policies.

Key Responsibilities:

• Develop, author, and maintain IT policies, Standard Operating Procedures (SOPs), plans, specifications, protocols, and reports.
• Lead and facilitate IT process improvement initiatives related to compliance and documentation.
• Serve as the Infrastructure Qualification Lead for PSG sites, ensuring qualification deliverables meet global and local requirements.
• Provide guidance to project teams on Global IT GxP processes, qualification strategies, and required compliance deliverables.
• Advise on and manage change controls in alignment with IT compliance and GxP standards.
• Collaborate with Global IT Shared Services to review and prepare GxP documentation for QA approval.
• Support the development and review of IT-related agreements and ensure compliance with regulatory expectations.
• Provide IT compliance support for audits, inspections, and continuous improvement activities.
• Support qualification and validation of mobile computers, scanners, and mobile devices used in GxP environments.

Required Skills & Qualifications -

• 5+ years of experience as a Technical Writer or in a related documentation/compliance role within the pharmaceutical or life sciences industry.
• Strong background in GxP compliance, IT validation, and regulated documentation processes.
• Proven ability to author and maintain policies, SOPs, plans, protocols, and reports.
• Experience with infrastructure qualification, change control, and validation documentation.
• Excellent verbal and written communication skills with high attention to detail.
• Experience in audit support and regulatory inspections.
• Skilled in user training and documentation facilitation.
• Proficiency in SharePoint, ServiceNow, and Power BI.
• Manufacturing environment experience is an advantage.

Education -

• Bachelor s degree in Information Technology, Computer Science, Engineering, Life Sciences, or a related field.
• Advanced degree (Master s) preferred but not required.

Preferred Experience:

• Prior experience with pharmaceutical IT compliance, GxP infrastructure qualification, and QA collaboration.
• Strong understanding of IT systems and lifecycle documentation in regulated manufacturing environments.
• Demonstrated ability to collaborate cross-functionally with global and local teams.