Quality Assurance Specialist II, Raw Materials

Location:

Durham, NC, US

Company: oxfordbiom

Join Us in Changing Lives

Location: on-site role, Durham, NC

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 Quality Assurance Specialist, Raw Materials, to join our team. In this role, you will be providing quality oversight of activities supporting the end-to-end production process in accordance with OXB policies, standards, procedures and cGMP. , playing a key part in advancing our mission and making a real difference.

Your responsibilities in this role would be:

• Lead risk assessments and author technical reports for new raw material enrolment and open-container expiry.
• Support phase-appropriate material enrolment, including drafting specifications and leading the Material Enrolment Board.
• Present and manage Change Controls from initiation to closure; evaluate Supplier Change Notifications (SCNs) and ensure timely completion.
• Act as subject matter expert for raw materials and compendial testing, performing impact assessments, deviations, CAPAs, and related change actions.
• Conduct routine raw material testing (e.g., pH, conductivity, appearance, USP gas testing), inspection, and sampling.
• Collaborate cross-functionally to support new material onboarding, release, and project activities.
• Support preparation, participation, and follow-up for regulatory inspections, internal audits, and client audits.
  
  

We are Looking For:

• Bachelor’s degree or higher in Life Sciences.
• Minimum 7 years of experience in the pharmaceutical or biopharmaceutical industry, including at least 5 years in Quality Control, Quality Systems, or Quality Assurance.
• Proven experience managing Change Controls, Deviations, and CAPAs.
• Strong knowledge of current Good Manufacturing Practices (cGMP).
• Demonstrated ability to drive a quality-focused culture, build effective processes, and collaborate across multiple sites and stakeholders in a fast-paced environment.
  
  

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 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?

Nearest Major Market: Durham

Nearest Secondary Market: Raleigh