Manager, Digital Quality Systems
About The Position
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 Manager, Digital Quality Systems to join our Quality. In this role, you will provide leadership and oversight for the quality and compliance of computerized and software systems, including laboratory instrumentation, across all phases of the System Development Life Cycle. You will 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, playing a key part in advancing our mission and making a real difference.
Requirements
- This role does not offer sponsorship for work authorization.
- External applicants must be eligible to work in the United States.
Responsibilities
- Provide quality oversight for computerized and software systems, including laboratory instrumentation, 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 (e.g., 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/QC, 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/assist with vendor audits and oversee risk-based digital system validation assessments.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
