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Full-time
bachelor degree
Competitive total reward packages, Wellbeing programs, Career development opportunities, Supportive, inclusive, and collaborative culture
Posted 44d ago
Apply by Aug 13
~40 hrs/week
Responsibilities
The Senior Specialist will oversee raw material management, including sampling, inspection, and release, while acting as a subject matter expert for the enrollment process. They will also manage QMS records, support regulatory audits, and collaborate cross-functionally to ensure compliance and process improvements.
Requirements
Candidates must hold a Bachelor’s degree or higher in Life Sciences and possess at least 5 years of experience in the pharmaceutical or biopharmaceutical industry. Strong knowledge of cGMP and proven experience in managing quality systems like Deviations and CAPAs are required.
Full job description
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 Quality Assurance Senior Specialistto join our Quality Assurance team. In this role, you will be accountable for quality oversight of raw material management including coordinating shipping and testing with contract testing labs, sampling, inspection, and release, playing a key part in advancing our mission and making a real difference.
Your responsibilities in this role would be:
Act as subject matter expert for raw material enrollment process at OXB Durham.
Conduct raw material sampling and inspection.
Collaborate with Manufacturing, MS&T and QA to complete phase appropriate Raw Material Risk Assessments.
Collaborate with material suppliers to ensure proper supporting documentation is provided to OXB Durham.
Quality oversight of method lifecycle and method implementation strategies
Quality oversight of day-to-day QC operations
Support regulatory inspections, internal audits, and client audits.
Build and maintain cross-functional relationships with OXB colleagues and clients to collaborate, improve processes, and solve problems efficiently
Independently escalate compliance concerns when observed
QA support and ownership of QMS records including investigations, change controls, CAPAs, etc.
Navigate compendia (USP and EP) to support material testing requirements and RM spec creation
Final disposition of raw materials
Support Supplier Change Notifications and facilitate impact assessment completion, with cross-functional teams, in QMS
We are Looking For:
Bachelor’s degree or higher in Life Sciences.
Minimum 5 years of experience in the pharmaceutical or biopharmaceutical industry, including Quality Control, Quality Systems, or Quality Assurance, with at least 3+ years in Quality Control.
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 (LSE: OXB) is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy 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, OXB has 30 years of experience in viral vectors; the driving force behind the majority of cell and 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), adenovirus and other viral vector types. OXB’s world-class capabilities range from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.
OXB offers a vast number of technologies for viral vector manufacturing, including a 4th generation lentiviral vector system (the TetraVecta™ system), a dual-plasmid system for AAV production, suspension and perfusion process using process enhancers and stable producer and packaging cell lines.
OXB, a FTSE250 and FTSE4Good constituent, is headquartered in Oxford, UK. It has development and manufacturing facilities across Oxfordshire, UK, Lyon and Strasbourg, France, Bedford MA, and Durham NC, US.
Why Join Us?
💸Competitive total reward packages
🧘Wellbeing programsthat support your mental and physical health
🚀Career development opportunitiesto 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.
OXB (LSE: OXB) is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy 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, OXB has over 30 years of experience in viral vectors; the driving force behind the majority of cell and 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), adenovirus and other viral vector types. OXB’s world-class capabilities range from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.
OXB offers a vast number of technologies for viral vector manufacturing, including a 4th generation lentiviral vector system (the TetraVecta™ system), a dual-plasmid system for AAV production, suspension and perfusion process using process enhancers and stable producer and packaging cell lines.
OXB, a FTSE250 and FTSE4Good constituent, is headquartered in Oxford, UK. It has development and manufacturing facilities across Oxfordshire, UK, Lyon and Strasbourg, France, Bedford MA, and Durham NC, US. Learn more at www.oxb.com and follow us on LinkedIn and YouTube.
Offices: Windrush Court, Transport Way, Oxford, Oxfordshire OX4 6LT, GB · Harrow House, County Trading Estate, Transport Way, Cowley, Oxford OX4 6LX, GB · Unit 5, Oxford Industrial Park, Yarnton, Oxfordshire OX5 1QU, GB · Alec Issigonis Way, Oxford Business Park, Oxford, England OX4 2ZY, GB · Building 9400, Alec Issigonnis Way, Oxford Business Park, Oxford, OX4 2HN, GB
Gene therapyImmunotherapyViral vector GMP manufacturingCell and gene therapyLentiviral VectorsAAV Cell therapyCDMOGMPProcess Development
How many Manufacturing jobs are open in Durham, NC right now?
There are currently 549 open manufacturing positions in Durham, NC listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Manufacturing roles in Durham, NC?
Companies currently hiring include KBI Biopharma, PowerSecure, Inc., Analog Devices, Wolfspeed, LCI, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Manufacturing jobs in Durham, NC?
Yes — 67 of the 549 open manufacturing positions offer remote or hybrid work (19 remote, 48 hybrid).
How do I apply for Manufacturing jobs in Durham, NC?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.