Senior Manager, Quality Systems and Compliance

Senior Manager, Quality Systems and Compliance

Location:

Durham, NC, US

Company: oxfordbiom

We’re currently recruiting for a Senior Manager, Quality Systems & Compliance to join our Quality team. In this role, you will be a key leader within the Quality organization, responsible for overseeing and strengthening site quality compliance and quality systems to ensure ongoing adherence to established quality standards and regulatory requirements, playing a key part in advancing our mission and making a real difference.

• 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.

• 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.
• Experience in, or working knowledge of, cell therapy and/or gene therapy manufacturing, including material collection, processing, and upstream manufacturing, preferred but not required.
• 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.

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