Manager, Quality Risk Management Systems

oxfordbiom•Durham, NC

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 Quality Risk Management (QRM) to join our Quality Assurance team. You will act as or support the Local Process Owner (LPO) to ensure that the QRM Program is aligned with policies and applicable regulations, playing a key part in advancing our mission and making a real difference.

Requirements

Bachelor’s degree with at least 6 years of experience; Master's degree with at least 3 years of experience; or an Associate’s degree with 8 years of experience
Significant experience with like industry-related QRM
Mathematical calculation and complex data analysis ability
Demonstrated ability in developing scientific reasoning and problem solving with minimal coaching, as well as excellent written and oral communication skills.
Excellent negotiation skills and be able to frequently resolve issues with a focus on QRM.
Demonstrated skill in developing solutions and will do so with a flexible approach to the development of options.

Responsibilities

Lead the Quality Risk Management (QRM) Program for the Site to ensure compliance with site policies and regulations.
Ensure that all aspects of the QRM Lifecycle & Program are implemented and functioning properly within the Site's Quality Systems (including Risk Assessment, Risk Control, Risk Review and Risk Communication).
Manage the deployment of Risk Facilitators and QRM training needs (including QRM tools).
Act as a Change Agent with OXB QRM process Stakeholders. Influence QRM Process Owners, Network and Site colleagues to advocate for QRM best practices.
Provide guidance, direction and governance to QRM teams and leaders to ensure consistent application of QRM principles.
Design and implement QRM tools to address full range of emerging needs and applications.
Maintain QRM repositories in the QMS, including lifecycle management of approved Quality Risk Assessments (QRAs).
Act as the Subject Matter Expert (SME) for QRM at site to support audits and inspections. Provide strategic direction for responses to audit QRM/QAR topics.
Lead and maintain Site QRM Local Work Instructions (LWIs) according to the Document Management Procedures in the QMS
Lead Site implementation, monitoring and continuous improvement of the QRM practices. Identify site colleague training requirements, establish/lead process governance and track local Key Performance Indicators (KPIs).