Overview CoRegen is a mission-driven biotechnology company built by a world-class leadership team with experience at some of the most prominent and respected companies in life sciences. We are united by a shared commitment to scientific advancement, operational excellence, and meaningful impact on patients’ lives.

As we continue to grow, we are seeking a highly motivated Director of Quality candidate with required, hands-on experience in the cell and gene therapy industry to lead quality operations and compliance across the company’s GxP activities, with a primary focus on GMP quality systems, external partner oversight, and cGMP readiness in support of our cell therapy pipeline. Operating within a virtual model, this individual will provide strategic and hands-on leadership for quality oversight of CDMOs, testing laboratories, and other GxP vendors, while also ensuring appropriate internal oversight of GCP quality activities through collaboration with external consultants. The ideal candidate will bring deep quality operations experience, strong judgment, and the ability to build scalable, phase-appropriate quality infrastructure in a fast-paced development environment.

The Opportunity This position is fully remote and reports to the Chief Technical Officer. Candidates must reside in the United States to support our Quality Operations team, occasional travel within the United States will be required.

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.

• Serve as the company’s primary quality leader, providing 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.

• Serve as the primary quality point of contact for assigned CDMOs and external partners, building strong and effective working relationships.

• Establish, review, 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.

• Provide quality support for onboarding new external partners, technologies, and service providers.

• Support regulatory submissions and health authority interactions by ensuring quality systems and records appropriately support CMC and clinical activities.

Qualifications:

• Bachelor’s degree in a scientific, engineering, or related discipline required; advanced degree preferred.

• 10+ years of relevant quality experience in biotechnology or pharmaceuticals, with increasing responsibility in GxP quality leadership roles; cell and gene therapy experience is required.

• Strong cell and gene therapy experience required in GMP quality operations and external partner oversight, particularly in a virtual or outsourced operating model.

• 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.

Who You Are:

• A strategic hands-on leader with the ability to build while executing.

• Collaborative and pragmatic, with a strong commitment to patient safety and product quality.

• Comfortable operating in ambiguity and helping shape infrastructure in a growing organization.

• Able to influence across functions while maintaining high compliance standards.

• Committed to fostering a culture of quality, accountability, and continuous improvement.

Why Join CoRegen

CoRegen is a mission-driven biotechnology company built by a world-class leadership team with experience at some of the most prominent and respected companies in life sciences. We are united by a shared commitment to scientific advancement, operational excellence, and meaningful impact on patients’ lives.

You will work alongside accomplished executives with deep experience across leading Life Science organizations. You will be part of a collaborative, respectful, and mission-focused culture where your contribution truly matters and is grounded in mutual respect. We believe high performance and kindness can coexist. We value thoughtful communication, intellectual rigor, and proactive partnership. While we move with urgency, we also prioritize preparation, alignment, and teamwork.

If you are looking for a role where you can combine strategic thinking, operational precision, and meaningful impact, we would like to meet you.

We offer a comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family), a 401(k) plan, paid sick days, generous paid holidays, and unlimited PTO.

CoRegen is required by state specific laws to include the salary range for this role when hiring a resident in applicable locations. This role’s base salary is expected to be $215,000 - $250,000 USD annually. Actual pay depends on many factors including geographic location, your experience, training, and unique skills. The range may be updated as company or market needs evolve.