Quality System Project Specialist (FTC)

Bit Bio; Cambridge; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A biotechnology company in Cambridge seeks a Quality System Project Specialist to lead the implementation of a new electronic Quality Management System. This role involves project coordination, user training, and ensuring compliance with regulatory standards. Ideal candidates will have experience with eQMS platforms and hold a relevant degree. Join a dynamic team that values collaboration and innovation while contributing to advancements in the field of biology.

Benefits

Dynamic work environment

Opportunities for personal development

Innovative projects and cutting-edge technologies

Qualifications

• Demonstrable experience in Quality Assurance or Quality System Support role.
• Experience in regulated industries such as pharmaceuticals or biotechnology.
• Additional training in Quality Management or Project Management is advantageous.

Responsibilities

• Lead and support the eQMS implementation project.
• Conduct user acceptance testing (UAT) and document outcomes.
• Develop training materials and deliver sessions to end users.

Skills

eQMS platforms experience (e.g., Dot Compliance, Veeva)

Strong understanding of quality systems

Excellent communication skills

Project management skills

Attention to detail

Education

Bachelor’s degree in a relevant scientific, quality or engineering discipline

Tools

eQMS platforms (Dot Compliance, Veeva, MasterControl)

Job description

bit.bio is an award-winning spinout from the University of Cambridge. Our breakthrough technology combines synthetic and stem cell biology for the precise, efficient and consistent reprogramming of human cells used in research, drug discovery, and cell therapy. At bit.bio, we are passionate about engineering human cells that will enable the medicine of the future. To do this we need talented and curious people who want to make an impact on the future of science and therapeutics.

As a team of individuals, we value science, collaboration, openness, curiosity and creativity. We are united by trust and respect for each other.

Location: Babraham Research Park, Cambridge

Type: Full time, 9 month fixed term contract (FTC)

Office Based Position (Cambridge) - hybrid working available

This fixed-term contract is tied to project-based work and will run for the duration of the project.

Your role in our team:

The Quality System Project Specialist will lead and support the successful implementation of bit.bio’s new electronic Quality Management System (eQMS). This 9 month FTC role ensures that system configuration, process alignment, data migration and end-user training are delivered effectively, enabling a smooth transition to the new platform. The specialist will work closely with Quality, IT and cross-functional teams to ensure the eQMS is implemented in compliance with regulatory requirements and supports continuous improvement across the business.

Your key responsibilities will include:

• eQMS Implementation & Project Support
  - Coordinate and support all aspects of the eQMS implementation project including planning, configuration, testing and go-live activities.
  - Partner with internal stakeholders to define system requirements, workflows and quality process mapping.
  - Assist with data cleansing, preparation and migration from the legacy system to the new eQMS.
  - Manage documentation associated with the implementation including user requirements, test scripts, validation protocols and change controls.
  
  
• System Validation & Compliance
  - Support system validation activities, ensuring all requirements meet regulatory and internal quality standards (e.g., GxP).
  - Conduct user acceptance testing (UAT) with process owners and document outcomes.
  - Ensure all eQMS modules are configured in alignment with bit.bio’s Quality Management System and industry standards.
  
  
• Training & Change Management
  - Develop training materials, guides and SOP updates required for the eQMS rollout.
  - Deliver training sessions to end users across departments and provide post-launch support.
  - Champion change management activities, acting as a point of contact for questions, issues and user feedback.
  
  
• Quality System Support
  - Support the review and optimisation of quality processes and documentation during the transition period.
  - Collaborate with the wider Quality team to identify opportunities to streamline workflows using the new eQMS capabilities.
  - Provide ongoing system troubleshooting, liaising with the vendor as required.
• Hold a minimum Bachelor’s degree qualification (or equivalent experience) in a relevant scientific, quality or engineering discipline.
• Have demonstrable experience in a QA or Quality System Support role working with electronic Quality Management Systems (eQMS), ideally in implementation or system administration.
• Demonstrate ability to manage or contribute to cross-functional projects.

With essential experience in…

• Experience with eQMS platforms, such as e.g., Dot Compliance, Veeva, MasterControl, TrackWise, Q-Pulse etc.
• Strong understanding of quality systems and processes (e.g., Document Control, Deviations, CAPA, Change Control, Training).
• Experience of working in regulated industries such as pharmaceuticals, medical devices, biotechnology or related GxP environments.
• Experience in digital transformation or system migration programs.
• Strong attention to detail, documentation skills and understanding of validation and compliance requirements.
• Excellent communication, stakeholder engagement and project management skills.
• Additional training or certification in Quality Management or Project Management is advantageous.
• Knowledge of ISO 9001, GMP or similar regulatory frameworks.
• Experience with Dot Compliance eQMS platform.

More reasons to join us:

bit.bio provides a vibrant and dynamic work environment in an exciting, fast-moving time for biology. We work with cutting edge technologies and with our world-leading scientific advisory board. We conduct pioneering work with real-world impact.

We trust our people to make significant contributions early on with opportunities to be involved in projects that are key to the success and growth of our young company. We invest in people, creating opportunities for personal development in an inclusive multi-skilled team with ambitious goals that provide opportunities to learn on the job from each other.

Creativity and open minds are encouraged for everyone to contribute to the success of the company.

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