OXB · 1 day ago
Senior Specialist, Quality Assurance
Durham, NC
Full-time
Onsite
Senior Level
7+ years expOXB is a quality and innovation-led viral vector CDMO dedicated to enabling life-changing therapies for patients worldwide. The Quality Assurance Senior Specialist will oversee operations in an FDA-approved clinical cGMP manufacturing facility, ensuring compliance with quality standards and supporting critical manufacturing processes.
BiotechnologyGeneticsTherapeutics
No H1B
Responsibilities
Act as subject matter expert for cGMP compliance, operations and disposition
Oversee manufacturing activities within the production suites to support potential quality/compliance events, provide guidance on documentation comments and ensure compliance with applicable procedures
Provide manufacturing and floor support for critical operations, including but not limited to vial thaw, transfection and fill/finish
Review and approve executed GMP documentation such as batch records, logbooks, protocols and forms
Own the end-to-end batch disposition deliverables to meet client expectations
Create, review and approve GMP documentation such as master batch records, SOPs, protocols, reports, master templates, etc
Collaborate cross-functionally to support QA Raw Materials, Quality Systems, Technical Quality and Quality Control
Author, review and approve Deviations, Change Controls, and CAPAs
Review and approve alarm reports and disruption to controlled environment documentation
Oversee material shipments and quality hold of materials
Participate in site risk assessments
Perform area and process walkthroughs within Manufacturing, Warehouse, Quality Control and Utility areas
Ensure compliance with applicable procedures and production requirements. Perform follow-up on potential non-compliances and escalate to management as necessary
Support phase appropriate technology transfers as a quality expert
Support preparation, participation, and follow-up for regulatory inspections, internal audits, and client audits
Qualification
Required
Bachelor's degree or higher in life sciences discipline. 10+ years in a GMP regulated environment may be substituted in lieu of degree
Minimum 7 years of experience in the pharmaceutical or biopharmaceutical industry, including at least 3 years in Quality
Proven experience managing Change Controls, Deviations, and CAPAs
Strong knowledge of current Good Manufacturing Practices (cGMP)
Strong knowledge of compendial requirements
Demonstrated ability to drive a quality-focused culture, build effective processes, and collaborate across multiple sites and stakeholders in a fast-paced environment
Experience supporting risk assessments, regulatory inspections and tech transfers
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.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$217.05MKey Investors
Oaktree Capital ManagementSerum Institute of India Pvt. Ltd.
2025-08-01Post Ipo Debt· $60M
2021-09-22Post Ipo Equity· $68.08M
2019-05-01Post Ipo Equity· $69.83M
Leadership Team
Emily Yu
Oxford BioMedica CMO
Recent News
2026-01-16
2026-01-16
2026-01-16
Company data provided by crunchbase