Lead Specialist, Quality Assurance

oxfordbiom•Durham, NC

24d

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 Lead Specialist to join our Quality Assurance team. In this role, you will be accountable for supporting the quality management system and requirements for deviations, CAPAs, Change Controls, Lab Investigation, OO’s and Method Validations whilst making a real difference.

Requirements

Bachelor’s degree or higher in Life Sciences discipline
Minimum of 10 years of pharmaceutical or biopharmaceutical industry experience, with a minimum of 6 years in Quality Control, Quality Systems or Quality Assurance.
Hands-on experience with the management of Quality System Processes such as Change Control, Deviation, and CAPA is required.
In-depth knowledge of Good Manufacturing Practices (CGMP), Quality Management Systems, and applicable industry regulatory requirements
Experience with supporting regulatory inspections

Responsibilities

Independently supports as a quality approver in the Quality Management System for Change Controls, Deviations, Lab Investigations, OOSs, CAPAs, and Risk Assessments.
Works with initiators, investigators, and stakeholders to ensure change controls and investigations are initiated, performed, and closed within the required timelines.
Reviews CAPA investigation reports to assess the appropriateness of the identified corrective and preventive action(s) and CAPA effectiveness.
Provides support in the preparation for, conduct of, and follow-up activities associated with regulatory inspections, internal audits, and client audits
Ensures quality activities are carried out according to regulatory and quality requirements.
Participate in applicable network communities of practices and share best practices across the network as well as lead and/or support site and network initiatives.
Client interactions – Event and Change Control Notification to Clients, joint working sessions on investigations and technology transfers, and other client facing responsibilities.
Review & approval of product & process related change controls (includes Supplier Change notifications) and production documentation.
Support phase appropriate technology transfers, method transfers, and critical reagent programs.