Quality Systems Specialist - Change Control, Quality Processes – Global Change Control (temporary for 2 years)
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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
Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity!
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.
Seniority level
* Associate
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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