Associate Director, QMS (Quality Management Systems) & CSA (Computer Software Assurance)

About this role

Responsibilities

• Lead implementation and maintenance of scalable QMS across GxP functions
• Oversee core QMS processes including deviations, CAPA, change control, document management, and quality risk management
• Ensure QMS processes meet global regulatory requirements and industry expectations
• Establish and maintain CSA framework aligned with FDA CSA guidance and risk-based validation principles
• Oversee validation lifecycle activities for GxP computerized systems
• Partner with IT and system owners to ensure systems are implemented, maintained, and enhanced in a compliant state
• Drive adoption of risk-based validation approaches and ensure appropriate documentation and traceability
• Ensure ongoing inspection readiness for QMS and computerized systems
• Support regulatory inspections and internal audits related to QMS and CSA
• Review audit findings, drive CAPAs, and ensure effective resolution and continuous improvement
• Develop and maintain SOPs, work instructions, templates, and policies related to QMS and CSA
• Identify and implement process improvements to enhance efficiency, compliance, and scalability
• Support digital transformation initiatives and integration of quality systems
• Partner with CMA, Technical Operations, Regulatory, Clinical Development Operations, and IT teams to ensure alignment on quality system requirements
• Lead or mentor team members and contribute to building a strong quality culture