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.
Your role in our team:
We are looking for an experienced member of the Quality team to assist the Head of Quality with the development, implementation and maintenance of an integrated Quality Management System (QMS) across Bit Bio.
The initial aim of this role is to develop and implement Quality System processes to ensure the Quality, Safety and Efficacy of products, across all stages of the product lifecycle, within the Bit Bio product pipeline. The QA Manager will provide quality and compliance support to all departments and drive quality planning and continuous improvement activities to ensure the QMS is fully integrated into the organisation’s operational and business processes.
There is a requirement to be diplomatic, collaborative, customer focused, change agile, comfortable in leading and adapting to changing priorities in a rapidly growing business.
Your key responsibilities will include:
• Develop, implement and maintain Quality System processes and procedures at the Cambridge site including CAPA, risk management, non-conformances, change control and validation to ensure compliance with internal standards and relevant regulatory requirements.
• Provide leadership and support to document control specialist in the management and control of QMS documents and records to ensure preparation, control, review and approval is performed on a timely basis.
• Schedule, plan and perform internal audits in accordance with an approved schedule and progress and monitor corrective actions.
• Schedule, plan and perform due diligence and routine surveillance audits of third party contractors and suppliers to ensure compliance with company and regulatory compliance.
• Act as principal QA contact, in liaison with relevant departments, in the handling, reporting of quality issues which arise in the manufacture, testing, packaging and supply of materials or product (both internally and through external parties).
• Develop, implement and maintain an effective system for handling quality complaints and establish effective feedback mechanisms to determine whether the organisation meets customer requirements.
• Establish relevant KPI’s to monitor and measure the QMS to ensure conformity and to continually improve its effectiveness and provide status reports and updates to Senior Management at Quality Meetings.
• Provide quality representation at all Quality review meetings at local and site level.
• Develop, facilitate and maintain a training matrix (detailing training requirements for job roles) and Develop GMP and Quality related training programmes, ensuring training is delivered in accordance with company policy.
• Host customer audits and participate in regulatory site inspections.
• Ensure quality goals and objectives are cascaded down through the organisation.
• Proactively identify and determine current and future resource requirements – both people and systems – lead in the recruitment and establishment of both in a rapidly growing organisation.
• Support development of personnel by providing relevant training, tools, skills and motivation to provide opportunities for personal improvement and encourage contribution towards continual improvement.
• Have a degree level or equivalent qualifications in a relevant discipline.
• Are humble - sincere and secure - accepts own mistakes - prioritises team over personal goals.
• Are hungry - driven and proactive - goes above and beyond the call of duty to achieve company results.
• Are smart - astute and persuasive - uses emotional intelligence to lead and inspire colleagues.
With essential experience in…
• QA Management role within a cGMP environment
• Developing and implementing QMS
• Good Manufacturing Practice within a Pharmaceutical or related environment
• Good documentation Practice and principles of Data Integrity.
• Performing internal and external audits (IRCA lead auditor).
• Proficient use of Excel, Word and PowerPoint
• Excellent time management, organisation, and communication skills
• Experienced in working in a scientific / cell therapy environment
• Experienced in Continual Improvement Tools e.g. LEAN, 5S, Kanban, Kaizen, RCA, VSM
• Experience implementing and/or working with eQMS e.g. Trackwise, MasterControl, Q-Pulse
• QESH Management System / ISO9001 / PDCA Training
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.
To support Bit Bio staff and our culture further, we also offer a competitive salary, highly competitive benefits package including pension contribution scheme as well as health and life insurance.
Location: Babraham Research Campus, Cambridge
Type: Full time, permanent / Start: Immediate
Salary: Competitive / Hours: 40 p/w
Office Based Position
To be part of our dynamic, growing start-up team and share our vision to build together the leading cell coding company, please send your CV and cover letter to email@example.com