Director - Quality Control

oxfordbiom • Durham, NC

21h • Onsite

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 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.

Requirements

• 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

Responsibilities

• Provide end‑to‑end leadership and oversight of QC laboratory operations, including in‑process, release, and stability testing
• Provide end‑to‑end leadership and oversight of QC laboratory operations, including 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
• 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
• 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
• 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
• 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
• 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
• Partner with Engineering and Facilities on commissioning, qualification (CQV), and computer system validation activities
• Define user requirements for QC instrumentation and laboratory systems
• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director