Basel, Basel-City, Switzerland
14 hours ago
Quality Systems Specialist - Change Control, Quality Processes – Global Change Control (temporary for 2 years)

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

You will work within a team of Change Control experts and will collaborate with peers within the function and across the organization to identify, design, and execute fit-for-purpose Change Control solutions within the strategic framework set by the Quality Process Owner (QPO) for Change Control, driving the delivery and sustainability of a robust and regulatory compliant Quality Management System (QMS) element. You will ensure the timely completion of quality solution deliverables and partner with business/stakeholder, overseeing and providing regulatory and technical expertise in the delivery of high quality processes and solutions. You will contribute to functional, cross-functional, enterprise-wide or external initiatives that shape our technical landscape, business and healthcare environments. You will need strong strategic, collaboration and communication skills, as well as an entrepreneurial mindset, to evolve the way we design and deliver the QMS and to enable accelerated delivery medicines and access for our patients.

The Opportunity

Drive and contribute to continuous improvement and lifecycle management of the quality system (Global standard policies, procedures, IT systems, training, metrics) within the strategic framework set by the Quality Process Owner (QPO) for Change Control with input from:

Stakeholder/customer/squad member feedback

User input and suggestions

Internal and health authority audit observations

Self-identified execution issues

Changing regulations/requirements

Performance as demonstrated through metrics

Evaluate and monitor health and implementation of processes to promote both short and long term success to best serve the users.

Collaborate with other process responsible colleagues within the QMS and across the organization to deliver compliant solutions.

Who you are

You bring deep expertise in pharmaceutical quality systems, with a strong foundation in GMP regulations and change control. Your ability to build trusted relationships, navigate regulatory landscapes, and apply a risk-based mindset enables you to drive improvements and influence at every level of the organization. With proven experience in health authority interactions and a commitment to clarity, learning, and collaboration, you thrive in complex global environments.

Extensive knowledge of change control and GMP-regulated processes

Strong grasp of regulatory requirements and risk-based approaches

Experience hosting and presenting to Health Authorities

Ability to influence across all levels and functions

Strong communicator with clarity, transparency, and negotiation skills

Demonstrated innovation, flexibility, and collaborative mindset

Fluent in English, with readiness to travel (

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