Director, Quality Operations

What You’ll Do

• Quality Leadership and Strategy
• Lead the development, implementation, and continuous improvement of CoRegen’s phase-appropriate Quality Management System across GxP activities.
• Provide strategic guidance to senior leadership on quality risk, compliance, inspection readiness, and operational quality priorities.
• Build a scalable quality framework suitable for a virtual biotechnology company advancing cell therapy products from development into clinical manufacturing and beyond.
• Establish quality governance processes, metrics, and management review mechanisms to support informed decision-making and continuous improvement.
• Quality Operations and External Oversight
• Provide end-to-end quality oversight of external manufacturers, testing laboratories, and other GxP service providers supporting CoRegen programs.
• Build strong and effective working relationships with assigned CDMOs and external partners.
• Negotiate and maintain quality agreements with external partners, ensuring clear delineation of roles, responsibilities, escalation pathways, and quality expectations.
• Compliance
• Lead quality compliance activities across GMP, GCP, and other applicable GxP domains.
• Ensure the organization and its external partners maintain a state of inspection readiness, including preparation for sponsor audits, regulatory inspections, and partner assessments.
• Quality Systems
• Own and maintain core quality systems, including document control, training, deviations, CAPAs, change control, risk management, and supplier quality management.
• Ensure company procedures are fit for purpose, aligned with current regulations and guidance, and appropriate for stage of development.
• GCP Quality Oversight
• Provide internal oversight for GCP quality activities supporting CoRegen clinical development programs.
• Partner with Clinical Operations, Regulatory, and external GCP consultants to ensure phase-appropriate quality support for clinical trial execution.
• Cross-Functional Partnership
• Partner closely with Technical Operations, Manufacturing, Supply Chain, Regulatory Affairs, Clinical Operations, and senior leadership to support compliant program execution.
• Support onboarding new external partners, technologies, and service providers.
• Ensure quality systems and records appropriately support CMC and clinical activities.

What You Bring

• Bachelor’s degree in a scientific, engineering, or related discipline required; advanced degree preferred.
• 10+ years of relevant quality experience in biotechnology, pharmaceuticals, or cell and gene therapy, with increasing responsibility in GxP quality leadership roles.
• Strong experience in GMP quality operations and external partner oversight, particularly in a virtual or outsourced operating model.
• Experience supporting cell and gene therapy development and manufacturing strongly preferred.
• Working knowledge of GCP quality requirements and vendor oversight expectations; direct GCP quality experience preferred.
• Demonstrated experience with quality systems management, supplier quality, audits, deviations, investigations, CAPAs, change control, and inspection readiness.
• Experience establishing and negotiating quality agreements with CDMOs, laboratories, CROs, and other GxP vendors.
• Strong knowledge of FDA, EMA, ICH, and other applicable global GxP regulations and expectations.
• Proven ability to operate effectively in a fast-paced, development-stage company environment with evolving infrastructure.
• Excellent communication, leadership, and cross-functional influencing skills.
• Strong problem-solving skills and the ability to apply risk-based, phase-appropriate quality decision-making.

Preferred Qualifications

• Prior experience in autologous or allogeneic cell therapy, gene-edited products, or other advanced therapy medicinal products.
• Experience supporting early clinical development through later-stage readiness.
• Experience implementing or scaling quality systems in a startup or emerging biotech setting.
• Experience managing external consultants supporting quality, compliance, or clinical quality functions.