At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Quality and Safety Head Diagnostics opportunity is to have a combined role for Roche Diagnostics in Croatia and Slovenia  covering responsibilities of safety and quality ensuring that all is in accordance with Roche policies and procedures, and country specific regulations. The person acts as an intermediary between external parties and the company's departments for issues related to the quality and safety management system.

Important Note:
 

This role can be based either in Zagreb or Ljubljana)

 Your Impact:

Safety Board /Recalls and Customer Notifications 

Responsible for Complaints Management

Local Regulatory Processes Management

Lead Quality Audits management

Prompt execution of, and communications related to Safety Board decisions, pursuant to Safety Board instructions.

Send safety and Quality notifications (Marketing conditionally) and receiving Notifications receipts for Dia/DC Cro & Slo and providing information from local case handlers to global case investigators and timely closing logistic cases.

Serve as primary contact for local regulatory authorities related to complaints, recalls and/or corrective field actions

Develop and implement of local processes to capture, document, and manage inquiries, complaints, and logistics claims in a timely manner (SOPs)

Oversee training related to Quality and regulatory processes in the Affiliate and in accordance to the Biosafety requirements.

Specify requirements and co-ordinate or prepare local labeling of Roche Diagnostics products and provide regulatory training to employees as required to meet compliance with local laws and regulations. 

Plan and execute of regular audits of the Quality System in order to assure its compliance, suitability, efficiency and effectiveness, quality Evaluation of critical suppliers and management of corrective and preventive actions following internal audits, customer complaints, management reviews, non-conformities.

Who you are:

 University degree or equivalent qualification level in biomedical field /Scientific background

Experience in working in quality or safety (in pharma/diagnostics industry is an advantage)

Personal organization – highly organized with excellent ability to prioritize and manage multiple tasks

Excellent communication skills oral and written and ability to precisely articulate yourself

Pragmatic, self-motivated self-sufficient player driven to impact and displaying a service attitude

Team worker and collaborator

Fluent in English, either Croatian or Slovenian knowledge of both Croatian and Slovenian is an advantage)

Driving license 

Basic MS Office knowledge 

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.