Senior Manager, Quality Systems and Compliance

oxfordbiom•Durham, NC

26d•Onsite

About The Position

OXB is seeking a Senior Manager, Quality Systems & Compliance to join their Quality team. This role is a key leadership position within the Quality organization, responsible for overseeing and strengthening site quality compliance and quality systems. The goal is to ensure ongoing adherence to established quality standards and regulatory requirements, playing a crucial part in advancing the company's mission of enabling life-changing therapies to reach patients worldwide. The position is based in Durham, North Carolina, following the expansion of OXB's US footprint with the acquisition of a new commercial-scale viral vector facility.

Requirements

Bachelor’s degree in a scientific or technical discipline
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.
External applicants must be eligible to work in the United States.

Nice To Haves

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

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.