Manager

• Responsible for architecture of the Quality Management System and all infrastructure elements to affect an efficient and effective QMS and oversee, configure, and continually improve document management, change, and control processes.
• Report directly to the Director, Quality Assurance.
• Build organizational capability by leading, developing, and inspiring a global QMS and Document Services team; create clear pathways for professional growth and succession.
• Collaborate across functions (R&D, Operations, Clinical, Regulatory, IT, etc.) to embed QMS ownership and accountability throughout the organization.
• Act as a visible quality leader engaging senior stakeholders to align QMS and Document Services strategy with company objectives.
• Provide strategic oversight of document management, change control, and MasterControl-based processes and identify ways to streamline and strengthen compliance.
• Define and manage resource requirements and ensure the team is equipped to deliver against business and compliance needs.
• Champion the use of quality metrics to inform decisions, continuous improvement, and reporting to leadership.
• Represent Document Services and QMS functions in Management Review, audits, and inspections.
• Ensure compliance with relevant international regulations and continuously evaluate compliance risks, implementing mitigation strategies.
• Lead organization-wide initiatives to build capability and engagement with quality systems and ensure effective budget management.

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