GPC Global Compliance Assurance Lead

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The 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.

Who we are

A healthier future drives us to innovate. 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.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.