Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die Position
Mission
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.
You will act as a primary point of contact of GPC’s "Inspection Ready" status. By managing audit schedules, maintaining critical documentation, and liaising with Global Post Market Quality and Local Safety Officers, you will ensure that customer interactions and processes meet the highest legal and medical regulatory standards. You will identify systemic risks and implement corrective actions to maintain the integrity of our patient care operations.
Key Accountabilities
- 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.
- Audit Management: Lead the preparation and management of the GPC audit schedule; coordinate all "pre-work" to ensure the organization is prepared for internal and external inspections.
- 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.
- Audit Participation: Actively participate in GPC-relevant audits, providing evidence, responding to inquiries, and managing the documentation trail.
- 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.
- Regulatory Alignment: Ensure that all GPC activities remain in full alignment with medical device regulations, pharmacovigilance standards, and data privacy laws.
Key Skills and Experience
- Language: A fluent command of English is required; additional languages are a distinct advantage.
- Experience: Minimum 4 years of experience in Quality Management, Regulatory Compliance, or Auditing, preferably within a medical device, pharmaceutical, or highly regulated environment.
- Technical Knowledge: Strong understanding of Post Market Surveillance, Pharmacovigilance reporting, and relevant ISO standards.
- Attention to Detail: Exceptional analytical skills with the ability to spot minute deviations in documentation or agent workflows.
- Communication: Ability to communicate complex regulatory requirements to non-compliance stakeholders clearly and persuasively.
- Organizing skills: Proven ability to manage audit schedules, meet strict deadlines, and coordinate multi-departmental preparation efforts.
- Systems Literacy: Proficient in IT navigation and Quality Management Systems (QMS); ability to quickly learn new compliance tracking technologies.
- Mindset: Highly ethical, detail-oriented, and resilient. You must be comfortable working with autonomy while maintaining a collaborative approach with global safety teams.
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
