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OXB · 1 day ago

Lead Specialist, Quality Assurance

Durham, NC

Full-time

Onsite

Lead/Staff

10+ years exp

OXB is a quality and innovation-led viral vector CDMO with a mission to enable life changing therapies to patients around the world. The Lead Specialist in Quality Assurance will support the quality management system and ensure compliance with regulatory and quality requirements while overseeing various quality assurance activities.

BiotechnologyGeneticsTherapeutics

No H1B

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

Qualification

Quality Management SystemsManufacturing PracticesQuality ControlRegulatory InspectionsChange ControlDeviation ManagementClient InteractionTeam Collaboration

Required

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

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.

Founded in 1995

Oxford, Oxfordshire, GBR

501-1000 employees