Senior Director, Quality Systems and Compliance

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 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.

Responsibilities include but are not limited to:

Lead Allogenes 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.

Qualifications

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.

We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package which includes an annual performance bonus equity health insurance generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $230000 to $27000 per year. Actual pay will be determined based on experience qualifications geographic location business needs and other job-related factors permitted by law.

As an equal opportunity employer Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin gender age sexual orientation physical or mental disability genetic information or characteristic gender identity and expression veteran status or other non-job-related characteristics or other prohibited grounds specified in applicable federal state and local laws. We also embrace differences in experience and background and welcome diversity of opinions and thought designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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