Senior Manager, Global Quality Digital Systems

📋 Description

• • Provide strategic support for standardized digital quality systems programs across global operations to ensure compliance with regulatory standards and corporate policies.
• • Evaluate existing digital quality systems worldwide, identifying gaps and leading training initiatives for key personnel on global quality policies and procedures.
• • Actively participate in global inspection preparedness activities, audit responses, and CAPA resolution efforts specifically related to digital quality systems and their implementation.
• • Conduct independent research and interpretation of international regulatory frameworks including FDA, EMEA, TGA, Health Canada, WHO, PIC/S, MHLW, ICH, GxP, and other national and supranational requirements.
• • Review and approve critical system validation documentation such as user requirements, validation strategies, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), validation summary reports, and change requests within established timelines.
• • Independently assess and interpret departmental and corporate policies and procedures, providing clear guidance on regulatory applicability and compliance expectations.
• • Facilitate cross-functional meetings with management at all levels to align digital quality system initiatives with business objectives and regulatory obligations.
• • Offer expert guidance on managing digital quality systems to meet industry best practices, regulatory mandates, and corporate governance standards.
• • Perform detailed analysis of complex business and technical documents, translating regulatory language into actionable compliance plans for global teams.
• • Prepare comprehensive reports, business correspondence, and presentations for internal and external stakeholders, ensuring clarity and alignment with regulatory expectations.
• • Apply statistical analysis and interpret graphical data to support quality system improvements and risk assessments.
• • Demonstrate proficiency in performing pharmaceutical calculations, percentages, ratios, and rates relevant to quality system metrics and validation outcomes.
• • Solve moderately complex problems using semi-standardized approaches that require analysis, judgment, and ingenuity within defined procedural frameworks.
• • Supervise teams in accordance with organizational policies and legal requirements, including interviewing, hiring, training, performance appraisal, discipline, and conflict resolution.
• • Maintain high-level computer proficiency with Microsoft Office suite to support documentation, reporting, and data analysis tasks.
• • Communicate complex regulatory concepts diplomatically and effectively to business partners, auditors, and regulatory authorities.
• • Travel up to 30% domestically and internationally to support global quality initiatives, site audits, and training sessions.
• • Perform duties in a standard office environment with intermittent physical activity including standing, walking, stooping, bending, and climbing steps.
• • Ensure all activities comply with U.S. and international labor, safety, and employment regulations.
• • Maintain proficiency in reading, writing, speaking, and comprehending English as the primary language of communication and documentation.