Compliance Officer
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
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.
About the role:
Are you passionate about Information (IT) and Automation Technology (OT) and aspiring to make a meaningful impact? You are a leader who builds and shares an inspiring vision, able to catalyze performance and growth for people and business units?Are you curious to shape a digital manufacturing architecture, ready to advance competitiveness on the market?
We Make Medicines!:
Behind every product sold by Roche is Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes lifesaving medicines at 11 locations, with the support of partners from around the world.Information (IT) and Automation Technology (OT) teams are key in producing and delivering medicine to patients.
The Compliance Officer position offers a unique opportunity to shape departmental & network processes in alignment with the Pharma & IT vision. Reporting to the IT OT Site Head Kaiseraugst, you will be a member of the IT OT Manufacturing Network and ensure the departmental compliance.
The Opportunity:
- Own local regulatory documents, training curricula, and development of new strategies based on global specifications, integrating them into IT OT processes.
- Present ITOT processes and best practices during authority inspections and audits, supporting Global SMEs.
- Update and review SLAs/OLAs, ensuring documentation quality in line with GxP specifications.
- Collaborate in large/global meetings and projects for conceptual development and standardization of global specifications.
- Lead specialist role in local and global teams, interfacing with CSV Chapter and IT QA.
- Act as local Doc Spoc for global specification documents, making decisions on implementation and continuous improvement.
- Provide expert guidance to colleagues and shape knowledge in the field by adapting insights from scientific literature and other industries.
- Support diverse compliance activities, including periodic reviews, root cause analysis, and compliance training.
- Serve as the single point of contact for inspection management.
Who you are:
- Have experience in managing change and developing a long-term vision for an organization in line with corporate strategy and priorities
- Entrepreneurial mindset with a focus on continuous improvement, holistic thinking and problem solving, applying lean and agile methods
- Excellent communication skills at both global and local levels to technical and non-technical audiences
- Well connected. Demonstrate intellectual curiosity and integrity with a high level of self-awareness, empathy and listening skills. You live a “speak up” culture and promote a culture of trust.
- Works with an agile mindset, i.e. good enough rather than perfect, focus on “reuse before purchase before manufacturing”.
- Has an ability to quickly learn new topics, with a mindset of continuous improvement, learning and cross-functional thinking
- Creates an environment with strong team spirit, timely and effective communication, urgency, high motivation and inspires teams to achieve goals immediately and in the long term
- Proficient knowledge of pharmaceutical processes as well as cGXP regulations, CSV & ITSM/ITIL
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.