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Associate Director of Product Quality
2 months ago
Associate Director, Product Quality
Location: Cambridge
Type: Full time
Hours: 40 p/w
The Role:
As the Associate Director, Product Quality, you will play a crucial role in the production team, ensuring that the development, manufacturing, release, distribution, and continuous improvement of “research use only” differentiated cell products and services meet the required quality standards and customer expectations. Reporting to the Senior Director of Quality & Compliance, you will oversee production processes from a quality perspective, develop strategies with key teams to enhance product quality, and respond to customer feedback and internal data to drive improvements.
Key responsibilities will include:
- Ensure all products consistently meet high-quality standards.
- Represent the quality function within the wider product team.
- Conduct independent quality data reviews to support QC, stability, consistency, and process improvement efforts.
- Oversee supply chain quality, ensuring materials from suppliers meet quality, sustainability, and traceability requirements.
- Manage the complaint management system, including investigations of product or service complaints to identify root causes and implement corrective actions.
- Make timely decisions on product quality, halting product disposition if needed, and escalating issues to senior leadership.
- Develop and implement product quality plans that drive continuous improvement and meet organizational goals.
- Communicate quality issues and collaborate with product and technical teams to identify training needs.
- Manage and maintain production team quality standards, including work instructions and SOPs.
- Lead review meetings to assess performance, identify risks, and resolve any arising issues.
- Ensure quality records comply with good documentation practices and are properly maintained.
- Promote a culture where personnel can openly recognize and report quality risks or issues through appropriate channels.
- Collaborate with key stakeholders to establish product quality training programs.
- Actively participate in product team meetings.
- Contribute to the overall Quality and Compliance team by identifying improvement opportunities and ensuring compliance across operations.
Your Background:
- Hold a bachelor’s degree in a related discipline (or have equivalent experience).
- Have demonstrable experience in the Life Sciences industry in a Product Quality management role.
- Have experience working with biologicals or vaccine products.
- Are a solution-oriented problem solver with strong influencing skills.
Essential experience in:
- Managing product quality across the entire product lifecycle from development to launch and beyond.
- Leading and managing product quality teams.
- Knowledge of GxP principles and good documentation practices.
- Experience with change controls, non-conformances, root cause analysis, and CAPAs.
- Developing and executing internal audit programs; hosting external audits is preferred.
- Risk-based quality program development.
- Organizing and prioritizing tasks and special projects with minimal supervision.
- Building collaborative cross-functional working relationships and fostering a transparent environment.
And possibly…
- eQMS experience.
- Experience with iPSC technology.
- Practical experience in cell culture.
More reasons to join us:
We provide a vibrant and dynamic work environment with cutting-edge technologies. You’ll have the opportunity to contribute to pioneering work with real-world impact and be involved in key projects early on. We are committed to investing in personal development in an inclusive team environment with ambitious goals and opportunities to learn from each other.
