Join Us in Changing Lives
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Atย 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:ย 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'reย currently recruiting for aย Manager, Digital Quality Systemsto join ourย Qualityย team.ย In this role,ย you willย provide leadership and oversight for the quality and compliance of computerized and softwareย systems, acrossย all phases of the System Development Life Cycle. You willserve as the site Subject Matter Expert,ย for digital quality and data integrity, ensuring adherence toย GxPย requirements, corporate digital governance programs, and regulatory expectations, playing a key part in advancing our mission and making a real difference.ย
Please note this is a full time role, based on site in Durham, NC.
Your responsibilities in this role would be:
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Review and approve SDLC documentation, change controls, validation plans, URS, FRS, and related artifacts.ย
Lead site initiatives to align, harmonize, and standardize digital systems governance with corporate programs (e.g., SDLC, Data Integrity, Risk Management, Periodic Reviews).ย
We are Looking For:
Bachelor's degree or higher in IT, Computer Systems, Life Sciences, Engineering, or a related field.ย
Minimum of 5-7 years in the pharmaceutical/biotechnology industry, including IT compliance, digital quality, or computerized systems.
Comprehensive knowledge of global GMP regulations and guidance, including FDA, EU, ICH, GLP,ย GDocP, GDP, and GCP.ย
Strong experience in reviewing and approving system life cycle documentation, validation plans, change controls, and other digital quality artifacts.ย
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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.
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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.
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Why Join Us?
- ย Competitive total reward packages
- ย Wellbeing programsย that support your mental and physical health
- ย Career development opportunitiesย to help you grow and thrive
- ย Supportive, inclusive, and collaborative culture
- ย State-of-the-art labs and manufacturing facilities
- A company that lives its values:ย Responsible, Responsive, Resilient,ย ย ย ย ย ย ย ย 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?
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