Head of Regulatory Affairs & Quality Assurance (Director), Diagnostics

• Identify, assess, and communicate key regulatory requirements impacting Roche Diagnostics and the IVD industry to internal and external stakeholders.
• University degree majoring in a relevant subject, preferably Pharmaceutical and graduated as pharmacist, is required. A postgraduate degree (e.g. MSc or higher) in a relevant area would be desirable.
• Strategically align regulatory compliance with commercialization goals for continuous improvement and high-quality product delivery.
• Serve as a subject matter expert to the leadership team, offering guidance on quality, compliance, regulations, and clinical documentation for Indonesia registration/product licensing.
• Foster a culture of quality across departments by collaborating closely with company leaders.
• Analyze regulatory trends and initiatives, focusing on their impact on product registration, quality, certification, and other GXP commercialization requirements.
• Collaborate with internal and external stakeholders, particularly in manufacturing, to understand and inform strategic objectives for product registration, certification, and specified disease areas.
• Take strategic and tactical responsibility for all aspects of the Quality function, including building and maintaining Quality Systems.
• Lead the development and implementation of the Quality Management System to exceed customer expectations for product quality, delivery, and operational excellence.

• 10+ years of experience in experiences in Quality/Regulatory in Pharmaceutical/Diagnostics/Medical Devices industry
• Proven ability to establish and articulate a vision, set goals, develop and execute strategies, and track and measure results.
• Processes leadership and people influencing skills; Demonstrated success in establishing a high performing environment, catalyzing Roche Operating Principles cultural dimensions, with an excellent reputation attracting the best talent and the commitment to developing and inspiring them.
• Proven ability to create and sustain strong collaborative relationships and networks with diverse stakeholders across a complex global organization.
• Intrapreneurial mindset with proven ability to incubate and foster agile organizations within a complex, global corporate environment.
• Familiarity with the technological trends and their relevance to the healthcare industry. A passionate and decisive business leader. Demonstrating courage, vision and drive to achieve results at the forefront of innovative technological changes.

Roche