At Roche you can show up as yourself, embraced for the unique qualities you bring. As a GPC Compliance Assurance Specialist, you will be responsible for safeguarding the Global Patient Care (GPC) Organization by ensuring adherence to regulatory requirements, internal Standard Operating Procedures (SOPs), and safety protocols.
Your mission is to move beyond service quality to a rigorous model of Compliance Monitoring across all customer channels. By managing audit schedules, maintaining critical documentation, and liaising with Integral Post Market Quality and Local Safety Officers, you will ensure that customer interactions and processes meet the highest legal and medical regulatory standards.
Compliance Monitoring: Conduct regular, systematic compliance audits across all supported channels to ensure adherence to safety reporting and regulatory guidelines.
Documentation Management: Author, update, and maintain Standard Operating Procedures (SOPs) and relevant compliance documentation to reflect current global and local requirements.
Stakeholder Liaison: Act as the key point of contact for affiliate Local Safety Officers (LSOs) and Global Post Market Quality teams to align on safety reporting and quality standards. Corrective & Preventive Actions (CAPA): Identify compliance gaps and collaborate with leadership to design and implement corrective measures and process improvements.
Risk Mitigation:
Communicate significant regulatory risks or compliance deviations to local and global management in a timely and transparent manner. Ensure that all GPC activities remain in full alignment with medical device regulations, pharmacovigilance standards, and data privacy laws. A fluent command of English is required;
Experience: Minimum 4 years of experience in Quality Management, Regulatory Compliance, or Auditing, preferably within a medical device, pharmaceutical, or highly regulated environment. Ability to communicate complex regulatory requirements to non-compliance stakeholders clearly and persuasively. Proficient in IT navigation and Quality Management Systems (QMS); ability to quickly learn new compliance tracking technologies.
You must be comfortable working with autonomy while maintaining a collaborative approach with global safety teams. 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.