Associate Director, Product Quality

at  Bit Bio

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.

WITH ESSENTIAL EXPERIENCE IN…

• Working in product quality throughout the product management lifecycle from development through to launch and beyond.
• Proven experience of leading and managing product quality.
• Working knowledge of principles and practice of GxP and good documentation practice.
• Strong understanding of and experience with change controls, non-conformances, root cause analysis and CAPAs.
• Developing and executing internal audit and assessment programmes. Experience in hosting external audits is preferred.
• 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.
• Ability to build collaborative, productive departmental and cross-functional working relationships.
• Ability to foster a transparent and collaborative working environment and relationships.

YOUR ROLE IN OUR TEAM:

The Associate Director, Product Quality 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.
Reporting to the Senior Director, Quality & Compliance, the Associate Director, Product Quality will oversee the production processes, from a quality perspective, create and drive plans with other key functions to improve the quality of products, the product and receive and act on customer feedback and internal data to improve product quality.

YOUR KEY RESPONSIBILITIES WILL INCLUDE:

• Ensure every product achieves bit.bio standard of quality.
• Represent quality as part of the wider product team.
• Perform independent quality data reviews to support QC, stability and consistency assessments, and ongoing process improvement initiatives.
• Have 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.
• Oversee and manage the complaint management system and facilitate 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.
• Develop and implement a product quality plan to achieve quality objectives and drive continuous improvement with a focus on efficiency and effectiveness.
• Communicate with colleagues on quality concerns and identify quality training requirements for product, technical or lab-based teams.
• Manage and develop quality within the production teams, ensuring work instructions, SOPs or other production methods or standards are in place and available.
• Own and run disciplined and effective review meetings that drive assessment of performance against targets, identify risk areas or adverse trends, and drive solutions for any issues identified.
• Ensure quality records are fully completed in accordance with good documentation practices and are appropriately reviewed/approved and stored.
• To encourage and motivate personnel to recognize risks and quality issues and highlight them via the appropriate channels or via a confidential mechanism.
• Identify training needs and establish (in collaboration with other key stakeholders) product quality training programmes.
• Attend and be an active participant on any key product team meetings.
• Perform assessments and feed opportunities for improvement into the wider Quality and Compliance team, identifying opportunities for improvement and compliance to processes across all bit.bio operations.