Senior Director, Quality Systems and Compliance

Allogene Therapeutics•South San Francisco, CA

2d•Hybrid

About The Position

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on demand, more reliably, and at greater scale to more patients. About the role: As we expand and move toward clinical and commercial milestones, we are seeking a Senior Director of Quality Systems and Compliance to shape and lead our quality and compliance strategy. The ideal candidate is an individual who thrives in a fast-paced, dynamic, and highly collaborative biotech environment, and is willing to successfully take on new challenges. In this role, you will define and execute the global compliance strategy for clinical development programs in preparation for product commercialization. This role will lead the efforts to mature quality policies, processes, and systems to ensure compliance with global regulatory standards. You will provide strategic oversight over inspection readiness across the network, quality systems, and quality risk management, and champion a culture of continuous improvement to support GxP activities across the organization. This leader will partner cross-functionally with Manufacturing, Regulatory, and Clinical Quality Assurance to foster a culture of quality and compliance throughout the organization. This position reports to the Senior Vice President, Quality. This role will be based out of our South San Francisco office, with the flexibility to work remotely up to two days per week.

Requirements

B.S. in Biological Sciences, Chemistry, Engineering. Advanced degree preferred.
Minimum 10-12 years' experience in Pharma/Biotech industry including 5-6 years management experience with focus on Quality Systems and Compliance.
In-depth knowledge of Quality Management System requirements (US, EU) for pharmaceutical and biotech commercial manufacturing and supporting activities.
Experience leading and managing regulatory inspections with Global Health Authorities. Successful experience with Pre-license Inspections/Pre-Approval Inspections is a plus.
Excellent interpersonal and communication skills clearly conveying findings to a variety of audiences, including senior management.
Adept at interpreting and managing risks, balancing operations excellence and regulatory requirements to implement improvements
Comfortable in a fast-paced small company environment with minimal direction and able to adjust based upon changing priorities.
Candidates must be authorized to work in the US.

Nice To Haves

Successful experience with Pre-license Inspections/Pre-Approval Inspections is a plus.

Responsibilities

Lead Allogene’s Quality Management System and ensure compliance with current Good Manufacturing Practice (cGMP) requirements and regulatory standards including FDA, EMA, ICH, and ISO.
As a member of the Quality Leadership Team and key advisor on global compliance policies and strategy, collaborate with peers and site leadership to ensure company goals and regulatory commitments and standards are adhered to.
Promote a strong culture of quality, built on ownership, accountability, collaboration, continuous improvement, and risk management.
Serve as the lead for internal inspection readiness activities, supplier audits, regulatory inspections, and health authority compliance related interactions.
Lead compliance risk management assessments, ensuring timely and effective remediation of findings, deviations, and CAPA.
Oversee supplier quality regulatory compliance and risk management programs that support sustainable inspection readiness.
Define and oversee initiatives to mature quality systems in preparation for PLI readiness and product commercialization
Advance digital solutions and continuous improvement initiatives that strengthen quality performance and optimize processes.
Develop, monitor, and communicate quality and compliance metrics and key performance indicators (KPIs) to leadership and governance committees.
Build, coach, and develop a high-performing team. Manage through effective coaching and communication, fostering a culture of accountability, while guiding team on risk-based decision-making.