Location: Babraham Research Park, Cambridge

Type: Full time, permanent

Salary: Competitive / Hours: 40 p/w

Office Based Position

Your role in our team:

The Product Quality Manager is an integral part of the production team ensuring that the development, manufacture, release, distribution, and continuous improvement of bit.bio’s “research use only” differentiated cell products and services are of the appropriate quality, consistency and meet customer expectations.

The Product Quality Manager will oversee the production processes, from a quality perspective, create plans with other key functions to improve the quality of products, and receive and act on customer feedback and internal data to improve production quality.

Your key responsibilities will include:

• Ensuring every product achieves bit.bio standard of quality and representing quality as part of the wider production team
• Performing independent quality data reviews to support QC, stability and consistency assessments, and ongoing process improvement initiatives.
• Supply chain oversight to ensure that materials sourced from suppliers are of the appropriate quality, are sustainable, have necessary traceability and that any material/ service non-conformances are appropriately investigated and resolved.
• Overseeing and managing the complaint management system and facilitating any product/service complaint investigations with a view to establish root causes and corrective actions.
• Make real-time decisions on the quality status of products and if necessary, halt product disposition and escalate to quality, operational and commercial leadership.
• Developing and implementing a product quality plan to achieve quality objectives and drive continuous improvement with a focus on efficiency and effectiveness into the wider Quality and Compliance team and across all bit.bio operations.
• Managing and developing quality within the production teams, ensuring work instructions, SOPs or other production methods or standards are in place and available.
• Owning and running effective review meetings that drive assessment of performance against targets, identify risk areas or adverse trends, and drive solutions for any issues identified.
• Ensuring quality records are fully completed in accordance with good documentation practices and are appropriately reviewed / approved and stored.
• Identifying training needs and establishing (in collaboration with other key stakeholders) product quality training programmes for product, technical or lab-based teams.
• Being an active participant in any key product team meetings.
• Performing assessments to determine compliance to processes, and to identify areas for improvement.

You…

• Will have a Bachelor's degree in a related discipline (or equivalent experience).
• Will have demonstrable experience of working in the Life Sciences industry in a related Product Quality role.
• Proven experience of working with biologicals or vaccine products.

With essential experience in…

• Working in product quality throughout the product management lifecycle from development through to launch and beyond.
• Working knowledge of principles and practice of GxP and good documentation practice.
• Change controls, non-conformances, root cause analysis and CAPAs.
• Developing and executing internal audit and assessment programmes. Proven experience in developing risk-based quality programmes.
• Ability to organise, prioritise, and deliver tasks and special projects after general instruction and with minimal supervision.
• Knowledge and experience of using an eQMS.
• Ability to build collaborative, productive departmental and cross-functional working relationships.
• Ability to foster a transparent and collaborative working environment and relationships.
• Are a solution-oriented problem solver.
• Have strong influencing skills.

…and possibly…

• Experience of iPSC technology.
• Experience in cell culture.
• Experience in hosting external audits.