Director, Quality Control
About the role
Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market. At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time. This position will report into the Senior Director of Quality responsible for the oversight and management of Quality Control (analytical and microbiological) at the Clinical and Commercial sites in Allendale, NJ. Responsible for managing the laboratories daily activities and continuous improvement initiatives to ensure compliance and client requirements are met.
Responsibilities
- Ensure production support and cGMP compliance.
- Manages laboratory resources (human resources and financial resources).
- Prepares and tracks budget and CapEx activities, including staff overtime and contractor budgets, within their scope of accountability and responsibility.
- Oversee implementation and maintenance of QC functional group standards, instruments, methods, cGMP documents, sample handling, and applicable electronic systems (including LIMs).
- Ensure analytical, micro and environmental monitoring programs adhere to current regulatory expectations.
- Manage method validation to support technical transfer activities.
- Ensure instrumentation is