Senior Manager, Supplier Quality
Quality | South San Francisco, CA | Full Time
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 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 www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
We are seeking a highly motivated individual for the role of Senior Manager, Supplier Quality to work in this exciting new area of cancer immunotherapy. In this role you will be responsible for the Supplier Qualification (SQ) program and will work cross-functionally to execute and improve SQ programs.
Responsibilities (include but are not limited to):
- Responsible for supplier questionnaires, quality agreements, classification and performance monitoring, supplier complaints, and change notifications.
- Responsible for leading and evaluating supplier qualification activities which may include facilitating audit agenda, reviewing audit reports, communicating findings, assessing audit responses, and determining risks.
- Assure adherence to audit schedule, management of audit closure for suppliers of raw materials and GxP services, and maintenance of the approved supplier list.
- Lead and contribute to complex departmental and cross functional initiative and special projects as identified by management to support the business need
- Develop, assess and report on supplier performance metrics to executive management (e.g. QMRs).
- Assure Supplier maintenance and periodic monitoring cycles are adhered to.
- Assure execution of the supplier-initiated change notification process is timely for processing of change impacts and coordination with Supply chain to manage any impacts.
- Assure Quality Agreements are developed with high quality and periodic review cycles are adhered to
- Provide training to other team members to ensure consistency and compliance to supplier qualification processes and procedures.
- Support the new supplier selection process and lead supplier audits as assigned
- Develop or assist in writing and developing quality management system processes, work instructions, and forms
- Hiring, managing, developing and mentoring staff/ contract worker
- Other duties as assigned
- Bachelor’s degree in Engineering, Chemistry or biological sciences required.
- Advanced degree, ASQ Auditor certification, or ASQ Quality Engineer certification preferred
- At least 6 years in quality assurance, manufacturing, QC or quality engineering
- Experience in auditing and supplier qualification in biopharmaceutical field required
- Extensive working knowledge of quality system requirements such as US FDA GMP, GCP, EMA, and ICH guidelines and have a proven track record of successfully implementing these requirements
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Proficient in MS Word, Excel, Power Point, Visio, Project
- Candidates must be authorized to work in the US
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.