Associate Director, External Quality

About the role

Allogene Therapeutics is a clinical-stage biotechnology company focusing on the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. The company is led by a management team with extensive experience in cell therapy.

Responsibilities

• Provides Quality leadership to meet the technical and compliance requirements
• Supports quality management system and provides direction and decision making with regard to quality operations
• Operates in a fast-paced, highly dynamic environment with key company work partnerships including both internal and external stakeholders
• Works directly with operating entities (internal and CMOs) to ensure that products meet all required quality standards and specifications
• Provides quality oversight of material suppliers
• Provides QA guidance and support for CMO and supplier qualification
• Executes Quality Assurance (QA) programs and activities, including assisting with training and auditing programs, reviewing SOPs, investigations, specifications, methods, reports, and manufacturing records
• Manages change notifications and CMO/supplier-initiated changes
• Manages CMO and supplier investigations and corrective actions
• Manages completion of audit observation responses in a timely and effective manner
• Aligns and negotiates Quality Agreement terms with internal stakeholders and external partners
• Collaborates and supports analytical transfers, qualification, and validation as needed
• Provides guidance with respect to regulations, guidelines, and emerging inspectional trends in developing Quality management systems and functionality
• Pro-actively and independently identifies and mitigates key cross-functional issues with limited need to escalate
• Supports the preparation of relevant sections of regulatory submissions and response materials
• Drives continuous improvement utilizing quality tools such as lean, six sigma, and risk management
• Delivers project status updates to senior/executive management as needed

Requirements

• At least 7 years of experience in bio-pharmaceutical field with manufacturing operations oversight experience
• Bachelor’s degree in engineering, chemistry or biological sciences required. Advanced degree preferred (education or training in cell culture and gene therapy a plus)
• Extensive working knowledge of quality system requirements such as US FDA GMP, EMA, and ICH guidelines and a proven track record of successfully implementing these requirements
• Knowledge of fundamental quality engineering principles such as process capability, process control, and structured problem solving, including root cause investigations
• Demonstrated ability to successfully interact with regulatory health authorities at inspections (prior experiencing leading inspections is required)
• Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment
• Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
• Proficient in MS Word, Excel, PowerPoint, Visio, Project, and statistical software