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

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. 
 

As Head ofRegulatory Affairs & Quality Assurance, you will be responsible for leading all regulatory and quality activities to enable PT Roche Indonesia (Diagnostics) to be commercially successful in the Indonesia IVD market.

In this role you will:

• 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.
   

Who you are:

• 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.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.