OXB · 17 hours ago
Senior Manager, Quality Systems and Compliance
Durham, NC
Full-time
Onsite
Senior Level
7+ years expOXB is a quality and innovation-led viral vector CDMO on a mission to enable life-changing therapies to reach patients around the world. The Senior Manager, Quality Systems & Compliance will oversee and strengthen site quality compliance and quality systems to ensure adherence to established quality standards and regulatory requirements.
BiotechnologyLife ScienceGeneticsTherapeutics
No H1B
Responsibilities
Lead and oversee site Quality Systems to ensure compliant, effective, and inspection-ready execution of deviation management, CAPA, change control, quality metrics, Quality Council governance, and health authority inspection readiness within a commercial cell and gene therapy manufacturing environment
Continuously optimize quality system infrastructure, processes, and procedures to support scalable commercial operations, advanced therapy manufacturing complexity, and evolving regulatory expectations
Partner with Corporate Quality Services & Compliance to ensure alignment and effective deployment of global Quality programs, standards, and continuous improvement initiatives at the site level
Ensure sustained compliance with applicable U.S. and EU cGMP regulations, global regulatory requirements, and industry standards relevant to advanced therapy medicinal products (ATMPs)
Lead site inspection readiness activities, maintaining a constant state of readiness and serving as the primary site coordinator for corporate, client, and regulatory inspections, including preparation, execution, and follow-up
Provide quality leadership for cross-functional risk assessments, including evaluation of product, process, and system risks inherent to cell and gene therapy manufacturing
Lead and support site gap assessments to proactively identify compliance risks, drive remediation, and strengthen quality system robustness
Chair or support the site Quality Council, delivering timely, data-driven insights on quality system performance to site leadership and management review forums
Provide strategic site-level input to support the continuous improvement and evolution of corporate quality systems for commercial advanced therapy operations
Proactively identify and resolve quality and compliance risks through collaborative, solutions-oriented engagement with cross-functional stakeholders
Qualification
Required
Bachelor's degree in a scientific or technical discipline with a minimum of 7–10 years of progressive experience in Quality Assurance and/or Quality Control, including direct involvement in compliance activities and health authority inspections
Strong working knowledge of GxP regulations, global regulatory requirements, quality systems, and applicable guidance documents, including ICH guidelines
Demonstrated ability to manage complex quality initiatives with strong organizational and project management skills, effectively balancing multiple priorities in a fast-paced, highly regulated environment
Proven experience communicating complex quality and compliance issues clearly and effectively, with the ability to influence outcomes and build productive relationships across site-level and global functions
Experience applying quality risk management principles, including impact and risk assessment tools, process mapping, and continuous improvement methodologies
Willingness and ability to travel domestically and internationally (up to 15%) as required to support business and quality objectives
Preferred
Experience in, or working knowledge of, cell therapy and/or gene therapy manufacturing, including material collection, processing, and upstream manufacturing
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
Company
OXB
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.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$217.05MKey Investors
Oaktree Capital ManagementSerum Institute of India Pvt. Ltd.
2025-08-01Post Ipo Debt· $60M
2021-09-22Post Ipo Equity· $68.08M
2019-05-01Post Ipo Equity· $69.83M
Leadership Team
Emily Yu
Oxford BioMedica CMO
Recent News
2026-01-16
2026-01-16
Company data provided by crunchbase