Lead Specialist ,Technical Quality

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, Technical Quality, to join our Quality Assurance team. In this role, you will support the TQ organization through coaching/guidance and quality oversight review, and reports related to process manufacturing and laboratory equipment qualification, technology transfer, and process validation. You will be playing a key part in advancing our mission and making a real difference.

Your responsibilities in this role would be:

• Lead, facilitate and/or participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones.
• Participate in investigations and risk assessments related to deviations/ complaints and changes
• Participate in project teams through all phases of projects - conceptual and detailed design, equipment procurement, construction, installation, start up, commissioning and qualification, and system release.
• Provide Technical QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.
• Provide Technical QA oversight to the qualification/validation, technical transfers, aseptic processing, regulatory approvals and commercial/clinical operations at the facility.
• Review and Approval of validation lifecycle documents and reports.
• Quality oversight of validation activities, for life cycle approach, following validation plans and complying with cGMP regulations and company procedures.
• Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required.
• Assist in the creation and maintenance of QA policies, SOP’s and reports in line with site requirements.
• Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
• Participate in and support risk management activities in line with relevant guidance and best industry practice.
• Assist in the execution of the internal audit program including the performance of audits are required.

We are Looking For:

• Experienced in the execution of equipment, utilities, facilities, technology transfer, process validation, and/or Quality oversight on these disciplines.
• Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
• Strong attention to detail and precision in preparing and reviewing GMP documentation.
• Experience in quality management systems such as Veeva Vault, SAP, Trackwise, KNEAT, etc.
• Demonstrated knowledge and application of regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
• Minimum of 12 years of total combined experience in quality assurance and/or validation within a GMP regulated pharmaceutical and/or biotechnology manufacturing environment (FDA, EMEA, MHRA).
• Bachelor's degree in Life Sciences, or Engineering and/or equivalent industry experience.
• Knowledge of GAMP requirements to the qualification and validation of computerized systems.

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 25 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 commercialisation. 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?