Rose BioSolutions offers career opportunities at the forefront of advanced therapy manufacturing. Join a world-class team shaping innovative, scalable solutions that support programs from early development through commercial launch.

About Rose BioSolutions
With decades of expertise, including plasmid DNA manufacturing since 1992, we provide seamless program continuity from early research through commercial supply across the US and EU, eliminating handoffs that delay progress.
At Rose BioSolutions, innovation, infrastructure, and expertise come together to accelerate advanced therapies from concept to commercialization.

The role · Open position
At Rose BioSolutions, our capabilities span foundational research with human immune cells and stem cells to the complete advanced therapy manufacturing continuum. We are an established operation with a world-class team of experts, and we apply our R.O.S.E standard to every program and relationship: Reliable, Outcome driven, Scalable, and Excellent!
This role will see you join the Keele site QA team reporting to the QA Leader (Systems). You will be responsible for maintenance of the site supplier assurance program. Maintenance of the internal and external audit programmes including, performing internal Audits, writing of internal Audit reports and agreeing appropriate CAPA. The role will also include working with the other departments on site reviewing and approving site training modules and role out.
At Rose, you are not just another layer in a large organization—you are a key contributor in a nimble, high-impact team. We offer:
Direct exposure to diverse and complex client projects across multiple modalities.
A collaborative, low-bureaucracy environment where ideas are heard and acted upon.
Opportunities to grow your technical expertise and take ownership of your work.
Close interaction with leadership and clients, enabling real influence on project outcomes.
Participate in the preparation of Vendor Risk Assessments
Track, Monitor, and Maintain Vendor Qualification and Re-Qualification, and respective documentation
Review Vendor Qualification Documentation and Vendor Change Notifications
Maintain the Keele Approved Vendor List
Review Vendor Past Performance
Archive all Qualification Documentation and Agreements
Maintenance of Internal and External audit programmes
Perform internal audits to ensure standards are being maintained to on site SOP’s and regulatory requirements.
Authoring internal audit reports
QA representative to support internal training initiatives and role out
Support Change Control, Deviation and CAPA management
Review and approval of Material Specification Sheets
Good communication, both verbal and written
High levels attention to detail
Enthusiasm to look for process improvement ideas
Proficient in Microsoft Word and Excel, strong administration skills
Understanding of GMP or other regulated environment
Previous Supplier/vendor assurance experience
Previous QA Experience
Previous audit experience
Knowledge of Sharepoint, Smartsheet and SAP
Impact: Every process we design is a step toward a cure. You’ll be making a real impact on the health of people in your community and across the globe.
Expertise: Work alongside a world-class team of scientists and operational leaders in a "no-ego" environment.
Stability & Growth: We offer the security of an established operation with the career growth opportunities of a rapidly expanding organization.
Competitive base salary with performance-based bonus opportunities.
Benefits to support and enhance your overall well-being.
Pension scheme
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