Systems Manager, Digital Quality

oxfordbiom•Durham, NC

4d•Onsite

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 team. In this role, you will provide leadership and oversight for the quality and compliance of computerized and software systems, 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. 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.

Requirements

Bachelor’s degree or higher in IT, Computer Systems, Life Sciences, Engineering, or a related field.
Minimum of 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.
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.

Nice To Haves

Familiarity with AI/ML, automation, and next-generation laboratory platforms is a plus.

Responsibilities

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 (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, 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.