Local Quality Responsible

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Purpose

The Local Quality Responsible (LQR): is a strategic partner of the Affiliate business and is considered an extended member of the global PD Quality (PDQ) Function.

The Local Quality Responsible (LQR) is 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.

You will also handle the Market Research and Patient Support Program. This is an operational governance and oversight role to ensure Market Research and Patient Support Programs (MAPs) are initiated and executed according to applicable quality standards by the respective MAP Owners. The position holder acts as a single point of contact for the Global Team.

This role reports directly to the Country Medical Director.

Challenges

Local Quality Activities:

• 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
• Lead the implementation of the global Roche Quality Management System (QMS) at Affiliate level to meet regulatory requirements
• Lead the process to measure the overall Affiliate Medical Compliance status and take actions as needed
• Lead the Risk and Opportunity management and escalation process at local level to proactively identify, manage, mitigate and escalate Medical Compliance risks
• Identify the need for establishing an affiliate quality monitoring strategy in collaboration with relevant local and global stakeholders, in the areas of QMS and Medical Compliance
• Support Audits and Inspections impacting Affiliates
• Undertake other quality responsibilities that may arise in emerging Quality areas (e.g. Healthcare Solutions, RWE, medical devices) as per business needs, work packages and/or as defined in local/global procedures, systems, regulations and requirements

Market Research and Patient Support Program:

• Devise strategic oversight plan within the Affiliate/Global Function to identify MAPs through budgeting, market and brand planning information
• Support the organization (activity/program owners) in the identification and classification of all activities that could potentially qualify as MRPs or PSPs

Who You Are

• You hold a Bachelor Degree in Life Science or equivalent is preferred
• You have 2 to 5 years of relevant experience within the pharmaceutical or biotechnology industry
• You have good understanding and demonstrated experience in Quality, Compliance, Regulatory and/or
• Validations in related GCP and GVP activities
• You possess business acumen with demonstrated expertise in QMS, Medical Compliance, Service Provider Oversight, CAPA and Risk Management, process simplification
• You have an experience/involvement in audits (and Health Authority inspections)
• You possess partnering and networking capabilities
• You are able to influence without authority
• You have a strategic mindset, System thinking, enterprise mindset

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.