Local Quality Responsible (LQR) Cross-country

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The Position

Local Quality Responsible (LQR) (cross-country role)

Purpose of the role:
The LQR is a strategic partner of the Affiliate business and is considered an extended member of the global PD Quality (PDQ) Function. They are responsible for ensuring that the Affiliate Quality Management System (QMS) and local Medical Compliance related activities are delivered in accordance with the applicable Roche standards, global and local quality strategy, and regulatory requirements. 
LQRs collaborate with Affiliate and Global colleagues to proactively enable Affiliate business while providing a quality framework for a healthy Affiliate QMS that protects patient safety, ensures reliability of Roche’s data and maintains the company’s license to operate while driving continuous improvement.

Roles and responsibilities: 

• Shape and advocate the Quality vision, transparency and consistency, to promote an enterprise  Quality Culture that ensures the highest standards of Quality and Medical Compliance.
• Design,  evolve and integrate the Affiliate QMS to facilitate high performance and networking across organizational boundaries based on business needs and regulatory requirements. Enable the realization of business opportunities by embedding quality-by-design mindsets with key stakeholders.
• Helps the affiliate and the LQR network to build the skills and mindset they need to succeed and make informed decisions.
• Connect the QMS and business strategies to create synergies, clarity and focus to accelerate outcomes, remove obstacles, and maintain high quality standards. 
• Act as a trusted Quality Partner for the local Enabling Team and the business by actively engaging on strategic decisions.
• Propose, lead, participate in and actively contribute to the Affiliate and Global Networks, by sharing knowledge, enhancing stakeholder collaboration, promoting quality mindset and co-creation of quality solutions.
• Build network with external parties/bodies (e.g. Quality Associations, Regulatory Authorities, Licensing Partners) to anticipate trends, address gaps, anticipate potential impacts to QMS, build trust, mitigate regulatory risks and enhance the Company's reputation. 
• As a SHE Officer at Roche Central Asia, you will ensure compliance with Roche Group SHE requirements and local laws. You will oversee security and environmental matters, maintain the business continuity plan, and coordinate SHE requirements across departments. Collaborating with senior management and employees, you will foster a safe and secure workplace and support strategic business initiatives.

Qualification/Knowledge and Experiences

• Strong business acumen with demonstrated expertise in QMS, Medical Compliance, Service Provider Oversight, CAPA and Risk Management, process simplification
• Demonstrated applied knowledge of ICH GCP, GVP and other relevant regulations and requirements, at a global and local level
• Understanding the Quality Principles of ISO standards (e.g ISO 9001 Quality Management System & ISO 31000 Risk Management and ISO 13485 Medical Devices)
• Experience in working with a cross-functional team and international network, preferably in a GxP function
• Experience/involvement in audits (and Health Authority inspections) is preferred
• Strong partnering and networking capabilities, ability to influence without authority 
• Excellent stakeholder (internal and external) engagement and effective collaboration skills) 
• Strategic mindset, System thinking, enterprise mindset
• Understanding of Data Analytics and ability to derive Qualitative insights
• Highly self-motivated and able to lead initiatives
• Fluency in English and Russian language
   

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.