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 Global Compliance Assurance Lead, you will play a key role in ensuring the GPC - Global Patient Care Organization has the highest quality standards and remains compliant at all times.
You will lead and manage a team of GPC Compliance Assurance Leads, Compliance Assurance Specialists and PRI& Case Monitoring Specialists. You will ensure Roche and partners' products and solutions meet global regulations, corporate standards, and expectations by overseeing the monitoring, reviewing, and timely reporting on the quality of interactions. You will help maintain an effective quality management system and governance, globally, and continually improve the governance to meet evolving business and compliance needs.
Together with your team, you will implement a common quality framework across the GPC Hubs. You will analyze results regularly, conceive corrective and preventive measures in case of findings, and collaborate in the design of training concepts to overcome identified knowledge gaps.
You will ensure the GPC Organization complies with regulatory requirements and corporate standards. You will communicate significant quality, or regulatory issues and risks that may impact operations or regulatory compliance to local, regional or global management. In addition, you will be accountable for the preparation, coordination, and conduct of audits, ensuring the GPC Organization operates in an “inspection ready” manner and that audit measures are strictly implemented.
Key Accountabilities
- Effectively lead and develop a team of GPC Compliance Assurance Leads, Specialists and PRI& Case Monitoring Specialists.
- Design, implement, and continuously improve the Global Compliance Governance Model and related monitoring standards.
- Accountable for the end-to-end audit process, including preparation work, managing the audit schedule, and ensuring the timely implementation of audit-related measures.
- Implement and follow up on measures to continuously maintain or optimize the overall compliance of GPC in the processing and documentation of customer concerns.
- Act as a contact person and expert with the different interfaces for all quality and compliance topics, proactively and in an advisory manner.
- Main responsible for auditing and analyzing the compliance levels of the cases handled by GPC Advisors.
- Close collaboration with global safety and post-market quality teams to ensure end-to-end compliance in the complaint handling process.
- Foster a culture of excellence, inclusivity, and collaboration while driving team and individual performance.
- Cultivate an inspiring team environment that promotes diversity, overcoming the challenges of a multi-location setup.
- Ensure the team delivers exceptional service while optimizing efficiency and effectiveness through continuous improvement.
- Drive the talent acquisition and hiring process, focusing on retaining top talent and maintaining a positive work environment.
- Provide proactive feedback and coaching to team members, managing performance and contributing to succession planning and talent management.
Key skills and Experience
- Bachelor's degree or equivalent professional experience.
- A fluent command of English is a must; any other language is a plus.
- Proven leadership experience, preferably in an international setting in a medical regulated environment.
- Knowledge of Roche products, solutions, and systems is recommended.
- Minimum 4 years of experience in Quality Assurance, Compliance, or as an Auditor, preferably in a medical regulated environment.
- Profound knowledge of audit-related topics, legal regulations regarding data protection, and medical device guidelines.
- Excellent communication and presentation skills with the ability to deal with complex information.
- Empathic, solution-oriented, and team-oriented approach; ability to work quickly and efficiently.
- Works with autonomy and flexibility, always with a teamwork attitude.
- Multi-tasking, agile skills, and flexible to adapt to changes.
- Always willing to learn and grow with an attitude to go beyond.
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.