Systems Manager, Digital Quality

Join Us in Changing Lives

Location:

Durham, NC, US

Company: oxfordbiom

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. With over 30 years of experience in viral vectors, 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, supported by robust quality‑assurance systems, analytical methods, and depth of regulatory expertise.

Manager, Digital Quality Systems – Quality team role. Provide leadership and oversight for the quality and compliance of computerized and software systems across all phases of the System Development Life Cycle (SDLC). Serve as the site Subject Matter Expert for digital quality and data integrity, ensuring adherence to GxP requirements, corporate digital governance programs, and regulatory expectations.

• Provide quality oversight for computerized and software systems across the SDLC.
• Review and approve SDLC documentation, change controls, validation plans, URS, FRS, and related artifacts.
• Oversee deviations, CAPAs, and continuous improvement activities associated with computerized systems.
• Lead site initiatives to align, harmonize, and standardize digital systems governance with corporate programs (SDLC, Data Integrity, Risk Management, Periodic Reviews).
• Act as the site Data Integrity steward, ensuring adherence to Resilience’s DI program and implementing DI controls for procured and in‑house systems.
• Maintain all digital systems in a state of inspection readiness.
• Present and defend digital quality and data integrity programs and associated verification artifacts during client audits and regulatory inspections.
• Support internal audits, customer audits, and regulatory inspections.
• Provide guidance to SMEs and site stakeholders on maintaining compliant and inspection‑ready digital systems.
• Serve as liaison between site functions (Tech Ops, QA, Validation) and central dQ/DI functions.
• Represent the site in quality leadership forums, site Quality Review Board, and corporate governance boards to adopt corporate digital quality and DI standards.
• Establish, monitor, and report on site‑based dQ/DI KPIs to site and corporate leadership.
• Lead or assist with vendor audits and oversee risk‑based digital system validation assessments.

• Bachelor’s degree or higher in IT, Computer Systems, Life Sciences, Engineering, or a related field.
• Minimum 5‑7 years in the pharmaceutical/biotechnology industry, including IT compliance, digital quality, or computerized systems.
• Hands‑on experience implementing and managing GxP‑compliant computerized system quality programs (COTS and custom systems).
• Demonstrated experience designing and enforcing data integrity controls in computerized systems.
• Experience managing high‑performance teams and influencing cross‑functional stakeholders.
• Familiarity with AI/ML, automation, and next‑generation laboratory platforms is a plus.
• Comprehensive knowledge of global GMP regulations and guidance, including FDA, EU, ICH, GLP, GDocP, GDP, and GCP.
• Strong experience in reviewing and approving system life‑cycle documentation, validation plans, change controls, and other digital quality artifacts.

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

• 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

Ready to make a difference?