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™) therapies for cancer. Led by a world-class management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit http://www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Job Description:
Allogene is seeking an Associate Director/Director of Quality Assurance to lead the Quality Assurance function in Newark. This position will require active engagement and strategic vision for the QA role in the company. The position will be responsible for building a company quality management system and providing direction and decision making with regard to quality operations. Role will entail operating in a fast-paced, highly dynamic environment with key company work partnerships including both internal and external stakeholders. Excellent communication skills and demonstrated ability to work well with others will be essential
Responsibilities include, but are not limited to:
- Provides Quality functional leadership including hiring and managing, high performing quality assurance staff designed to meet the technical and compliance requirements of a growing company.
- Review and approve utility/facility, method validation, qualifications and validation reports, change control documents, and technical reports.
- Directs the establishment of and has approval authority for quality assurance functions, systems, procedures, and specifications for raw materials and products.
- Establishes policies, practices, procedures and specifications to assure released products are manufactured under cGMP requirements and meet required standards for identity, strength, quality, and purity.
- Directs quality assurance management of discrepancies in raw materials, intermediates, drug substance, drug products, and final containers and assures timely investigations, resolution of issues and implementation of corrective/preventive measures.
- Oversees change control and document control and archiving processes.
- Provides company guidance with respect to regulations, guidelines, and emerging inspectional trends.
- Performs and oversees quality operations including lot disposition, deviation management, and supplier management.
- Develops and implements annual quality plans, departmental goals, action plans, and budgets.
- Independently reports quality metrics to site management through Management Review process.
- Drives continuous improvement utilizing quality tools such as lean, six sigma, and risk management.
- Collaborates with internal and external teams to support and guide with quality operational activities.
- Ensures cGMP training program is effective and followed by staff involved in GMP operations.
- Other duties as assigned.
Requirements:
- At least 10 years in a technical role in quality assurance, manufacturing, QC or quality engineering with demonstrated manufacturing plant experience with at least 5 years in a related management role.
- Bachelor’s degree in Engineering, Chemistry or biological sciences required. Advanced degree preferred (education or training in cell culture and gene therapy a plus), ASQ Auditor certification, ASQ Quality Engineer certification preferred.
- Experience in medical device or pharmaceutical bio-pharmaceutical field required.
- Extensive working knowledge of quality system requirements such as US FDA GMP, EMA, and ICH guidelines and have 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.
- Proficient in MS Word, Excel, PowerPoint, Visio, Project, and statistical software.
- Demonstrated ability to successfully interact with regulatory health authorities at inspections (prior experiencing leading inspections is required).
- 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.
- Ability to work independently and as part of a team.
- Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
- Candidates must be authorized to work in the U.S
As an equal opportunity employer, Allogene Inc. 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at http://www.allogene.com for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.
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