Senior Manager, Document and Records Management
Quality | Newark, CA | Full Time
About Allogene Therapeutics, Inc:
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.
Allogene is seeking a highly motivated, collaborative individual for the role of Senior Manager, Document and Records Management to manage and further deploy and improve GxP compliant processes and procedures for GxP document management and archival across the company. Initially, primary responsibility will be to finalize establishment of the document management processes and support for Allogene’s new manufacturing facility in Newark, CA.
The position will initially be based in Newark, CA and is required to be on-site.
Responsibilities include, but are not limited to:
- Develop and manage scalable document control and archival processes, and associated computer systems, for GxP activities across Allogene, in compliance with regulatory requirements and expectations
- Establish and enforce standards across the company
- Further develop document management processes for the Newark manufacturing facility including a GMP records management and archival process
- Establish process for migration of paper documents to electronic archival
- Develop, oversee, and execute document control procedures including the creation, routing, review, approval, distribution, periodic review and archiving of new and revised controlled documents
- Ensure training and/or guidance on document and records management is available and effectively deployed
- Manage document control team
- Drive improvement and effective use of Allogene’s Electronic Document Management System, Veeva QualityDocs
- Define resource requirements, identify and hire document management staff as needed
- Identify process and quality issues / discrepancies, and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner
- Other duties as assigned
Position Requirements & Experience:
- Ability to work independently, and work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
- Bachelor’s degree preferred or at least 5 years of experience in a GxP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility, ideally early clinical phases through commercial drug product
- Ability to function as a subject matter expert on GxP document management and archival practices
- Ability to interact effectively with staff at all levels in the organization
- Strong knowledge of GxP regulations and guidance documents pertaining to paper and electronic document management and archival
- Minimum of 2 years of management experience, in a document management role
- Excellent writing, editing and document formatting skills
- Ability to manage multiple assignments in collaboration with various department system owners
- Advanced skills with MS Office applications Word, Excel, as well as Adobe Acrobat
- Experienced with EDMS and LMS computer systems; experience with Veeva QualityDocs, including its business administration, a plus
- Ability to work in a fast-paced, start-up environment
- Excellent 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
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Strong interpersonal skills including 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.