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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.
The Opportunity:
Lead Implementation of QMS in the Affiliate
Lead the implementation of the global Roche QMS at Affiliate level to meet regulatory requirements.
Contribute to the continuous improvement of the global QMS by providing Affiliate insights.
Drive the implementation in the Affiliate of the global and local Quality strategies, objectives and initiatives, as applicable.
Drive and enable the overall CAPA management process at local level (self identified deviations, audits and inspections findings), and proactively identify related trends and risks, to lead continuous improvement.
Lead Affiliate Medical Compliance Oversight
Lead the process to measure the overall Affiliate Medical Compliance status and take actions as needed.
Lead the Affiliate Management Review (MRs) and Local Medical Compliance Office (LMCO) ensuring that key outputs are understood by senior management and appropriate decisions and actions are taken where necessary.
Lead Affiliate Risk & Opportunity Management for Medical Compliance
Lead the Risk & Opportunity management and escalation process at local level to proactively identify, manage, mitigate and escalate Medical Compliance risks.
Who you are:
Bachelor Degree in Life Science or equivalent is preferred
More than 5 years experience in a biopharmaceutical company or equivalent
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.
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.