Director - Quality Control

Join Us in Changing Lives

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 exciting new opportunities to join us.

We’re currently recruiting for a Director, Quality Control to join our team. In this role, you will provide strategic and operational leadership for the Quality Control function at OXB Durham. You will be accountable for ensuring compliant, efficient, and phase‑appropriate QC laboratory operations, including analytical testing, sample lifecycle management, method lifecycle oversight, data integrity, and laboratory systems.

As a key member of the Site Quality Leadership Team, you will partner cross‑functionally with Manufacturing, MSAT, Quality Assurance, Engineering, and external clients to ensure timely product disposition, sustained inspection readiness, and regulatory compliance.

Your Responsibilities in This Role Would Be:

QC Operations & Execution

• Provide end‑to‑end leadership and oversight of QC laboratory operations, including:
• In‑process, release, and stability testing
• Sample lifecycle management, chain‑of‑custody, and retain sample programs
• Ensure testing schedules align with manufacturing timelines and client commitments
• Drive execution and compliance of stability programs and associated protocols

Analytical Methods & Technical Leadership

• Lead analytical method lifecycle management, including:
• Method transfer, validation, verification, comparability, and retirement
• Provide technical leadership for complex assays typical in cell and gene therapy, including potency, viral vector, and cell‑based assays
• Establish and monitor method performance metrics and analytical trending

Data Integrity & Laboratory Systems

• Ensure robust data governance and integrity across QC systems (e.g., LIMS, ELN, LES, environmental monitoring systems)
• Lead implementation, validation (CSV), and ongoing optimization of QC laboratory systems
• Drive continuous improvement in data trending, visualization, and reporting

Investigations, Compliance & Inspection Readiness

• Lead and oversee laboratory investigations, including OOS, OOT, and deviations
• Ensure thorough root cause analysis, risk assessments, and effective CAPA implementation
• Maintain a continuous state of inspection readiness for global regulators (FDA, EMA, MHRA, etc.)
• Ensure adherence to cGMP, ICH, and regulatory expectations for advanced therapies

External Partnerships & Client Interface

• Serve as the primary QC point of contact for client programs
• Oversee contract testing laboratories and external QC service providers
• Ensure alignment with Quality Agreements and timely communication of results, risks, and issues

Materials, Equipment & Facility Support

• Oversee lifecycle management of critical reagents, reference standards, and control materials
• Define and maintain product specifications and sampling strategies
• Partner with Engineering and Facilities on:
• Equipment qualification, calibration, and maintenance
• Commissioning, qualification (CQV), and computer system validation activities
• Define user requirements for QC instrumentation and laboratory systems

People Leadership, Strategy & Governance

• Build, lead, and develop a high‑performing QC organization through:
• Talent acquisition, onboarding, training, and succession planning
• Foster a culture of accountability, quality excellence, and continuous improvement
• Define and execute QC strategy aligned with site and corporate objectives
• Establish KPIs and manage departmental budgets, resourcing, and performance metrics

We Are Looking For:

• Bachelor’s degree or higher in Life Sciences, Biology, Engineering, or a related discipline
• 15+ years of pharmaceutical or biotechnology industry experience, with at least 7 years in a QC or quality oversight leadership role
• Extensive knowledge of global GMP regulations for QC laboratory operations, data integrity, and stability programs
• Strong bioassay and analytical testing expertise
• Hands‑on experience leading GMP QC laboratories within a biologics or advanced‑therapy environment
• Proven people management experience with a track record of building and developing high‑performing teams
• Broad Quality and Regulatory CMC experience, including regulatory inspections and audits
• Experience presenting QC investigations and laboratory operations to inspectors and auditors

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.

About Us

OXB is a quality and innovation‑led viral vector CDMO with a mission to enable its clients to deliver life‑changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 30 years of experience in viral vectors — the driving force behind the majority of gene therapies.

OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno‑associated virus (AAV), and adenoviral vectors. Our world‑class capabilities span from early‑stage development through to commercialisation, supported by robust quality systems, analytical expertise, and deep regulatory knowledge.

Why Join Us?

• 💸 Competitive total reward packages
• 🧘 Wellbeing programs supporting mental and physical health
• 🚀 Career development opportunities to help you grow and thrive
• 🤝 Supportive, inclusive, and collaborative culture
• 🧪 State‑of‑the‑art laboratories and manufacturing facilities
• 🌍 A company that truly lives its values: Responsible, Responsive, Resilient, Respectful

We want you to feel inspired every day. At OXB, we’re future‑focused and growing fast. We succeed together — through passion, commitment, and teamwork.

Ready to Make a Difference?