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Product Quality Director
2 months ago
Job Title: Associate Director of Product Quality
Location: Remote
Type: Full-time
Hours: 40 hours/week
The Role:
As the Associate Director of Product Quality, you will play a crucial role in ensuring that our products meet the highest quality standards. You will oversee production processes, develop strategies to enhance product quality, and respond to customer feedback and internal data to drive improvements.
Key Responsibilities:
- 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.
Requirements:
- 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:
- 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.
Desirable Experience:
- eQMS experience.
- Experience with iPSC technology.
- Practical experience in cell culture.
About Us:
We are a leading recruitment agency specializing in the Life Sciences industry. We provide a dynamic work environment with cutting-edge technologies and opportunities for personal development in an inclusive team environment with ambitious goals and opportunities to learn from each other.
