Senior Executive, Technical Writing

Essential Functions:

• Lead the preparation, development, and maintenance of technical documents including standard operating procedures, work instructions, technical reports, and related materials in compliance with cGMP and regulatory requirements
• Establish documentation metrics and dashboards to track quality, compliance trends, and team productivity
• Collaborate with manufacturing, quality, regulatory, and engineering teams to gather technical information and translate it into clear, compliant documentation
• Review and approve existing documentation to identify gaps, inconsistencies, or areas requiring update and escalate findings to relevant stakeholders
• Ensure all technical documents accurately reflect manufacturing processes, equipment operations, and quality systems
• Provide guidance and review support to junior documentation staff on documentation standards and cGMP requirements
• Manage the document control lifecycle including creation, revision, review, approval, and archival of technical documents
• Maintain accurate and complete documentation records including document revision histories and change control logs
• Ensure all technical writing activities comply with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements
• Participate in process improvement projects and functional team initiatives to enhance documentation quality, efficiency, and compliance
• Prepare Process and Cleaning Validation Protocol and Reports

Additional Responsibilities:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

• 5 years or more in 5 - 8 Years