Lead Specialist, Quality Assurance

 Join Us in Changing Lives 

At OXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful. 

Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us. 

We’re currently recruiting for a Lead Specialist to join our Quality Assurance team. In this role, you will be the technical lead within Quality Operations in support of activities within QC and includes additional responsibilities in support of manufacturing, engineering, and supply chain, playing a key part in advancing our mission and making a real difference. 

Your responsibilities in this role would be: 

• Independently supports a quality approver in the Quality Management System for Change Controls, Deviations, Lab Investigations, OOSs, CAPAs, and Risk Assessments.  

• Works with initiators, investigators, and stakeholders to ensure change controls and investigations are initiated, performed, and closed within the required timelines.  

• Reviews CAPA investigation reports to assess the appropriateness of the identified corrective and preventive action(s) and CAPA effectiveness.  

• Provides support in the preparation for, conduct of, and follow-up activities associated with regulatory inspections, internal audits, and client audits  

• Ensures quality activities are carried out according to regulatory and quality requirements  

• Participate in applicable network communities of practices and share best practices across the network as well as lead and/or support site and network initiatives.  

• Client interactions – Event and Change Control Notification to Clients, joint working sessions on investigations and technology transfers, and other client facing responsibilities.  

• Review & approval of product & process related change controls (includes Supplier Change notifications) and production documentation.  

•  Support phase appropriate technology transfers, method transfers, and critical reagent programs. 

We are Looking For: 

• Bachelor’s degree or higher in Life Sciences discipline   

• Minimum of 10 years of pharmaceutical or biopharmaceutical industry experience, with a minimum of 6 years in Quality Control, Quality Systems or Quality Assurance.   

• Hands-on experience with the management of Quality System Processes such as Change Control, Deviation, and CAPA is required. In-depth knowledge of Good Manufacturing Practices (CGMP), Quality Management Systems, and applicable industry regulatory requirements   

• Experience with supporting regulatory inspections   

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States. 

About Us: 

OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 30 years of experience in viral vectors; the driving force behind the majority of gene therapies. 

OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXB’s world-class capabilities span from early-stage development to commercialization. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise. 

Why Join Us?  

• 💸 Competitive total reward packages  

• 🧘 Wellbeing programs that support your mental and physical health  

• 🚀 Career development opportunities to help you grow and thrive  

• 🤝 Supportive, inclusive, and collaborative culture  

• 🧪 State-of-the-art labs and manufacturing facilities  

• 🌍 A company that lives its values: Responsible, Responsive, Resilient,         Respect  

We want you to feel inspired every day. At OXB, we’re future-focused and growing fast. We succeed together—through passion, commitment, and teamwork.  

Ready to Make a Difference?