THE OPPORTUNITY

In Pharma Development Quality (PDQ) we strive for confidence in the integrity of our data and our processes, agility, and unrivaled transparency with health authorities, patients and society. Our work provides leadership, know-how and partnering on quality across Molecules (GCP), Products (Drug and/or Medical Devices), Pharma affiliates and global regulated processes.
We are looking for a Quality Lead who brings a diversity of thinking and technical experience in pharmacovigilance / drug safety. The Quality Lead will support the Roche/Genentech Organization through the design and delivery of pharmacovigilance related quality strategies. Quality strategies will have defined quality measures (critical to quality [CtQ] factors) and objectives based on business surveillance and the use of data analytics. The Quality Lead will generate evidence and actionable data through the conduct of audits to assess the quality status and to be able to demonstrate effective implementation of quality assurance to stakeholders and Health Authorities.

• Define process/affiliate level approach with appropriate measures (CtQ factors) to enable oversight and management of quality
• Design and implement quality strategies
• Assess specific risk areas on an ongoing basis, communicate to PDQ senior leadership and propose modifications to the quality strategy where necessary
• Actively lead or contribute in activities to assess quality status, including preparation, conduct, presentation and timely reporting of outcomes of audits, ensuring appropriate action plans are developed
• Establish strong partnerships/relationships with business stakeholders
• Prepare and present contextualized quality evidence, including conclusions, observations and associated compliance risks to business stakeholders and Pharma representatives
• Lead or support inspection preparation activities and management of Health Authority inspections