SENIOR MANAGER, GXP DOCUMENT MANAGEMENT & TRAINING ADMINISTRATION

Company: CARGO-Therapeutics
Location: San Mateo
Posted on: March 20, 2023

Job Description:

POSITION SUMMARY -
Reporting to the Senior Director of Quality Assurance and Systems, CARGO Therapeutics is hiring a Senior Manager, GxP Document Management and Training Administration within the Quality function of the CARGO Technical Operations Business Unit. This is a key role focused on providing day to day quality oversight and management of GxP documentation, recordkeeping, and GxP Training Administration. - The scope of the role includes managing the transition from a paper-based process to a validated, electronic system for GxP Document Management and Training Administration. In addition, the candidate will define, develop & maintain associated SOPS, work instructions and templates to facilitate compliant program management. - As an early-stage company, this is one of the initial roles in the quality organization and offers a great opportunity to be part of establishing the quality culture and making a broad impact. -The role is based in San Mateo, CA. -WHAT YOU'LL DO AT CARGO THERAPEUTICS -Key responsibilities of the Sr Manager GxP Documents and Training Administration includes: - - - - - - - In alignment w/internal procedures, approve manufacturing and quality records that support GMP operations - - - - - - - Manage the day-to-day operations related to document control and GxP Document and Records management - - - - - - - Create and own associated SOPs and work instructions related to document/records management and for Validated system access - - - - - - - Create and manage document templates (e.g. SOP, WI, Technical Report) to support organizational needs - - - - - - - Acts as the Veeva QualityDocs workflow / business system owner and administrator and support ongoing implementation and configuration of EDMS in alignment with CARGO business requirements - - - - - - - Create and own associated SOPs related to GxP Training Administration; Including how to create, manage, and maintain training requirements for CARGO GxP personnel - - - - - - - Develops and delivers training to CARGO personnel on how to use Veeva tool for document development and management as well as GxP training completion - - - - - - - Partner with functional area manager to ensure applicable training curriculum is defined, in place and assigned to new/existing personnel - - - - - - - Partner closely with Head of Quality Operations and Systems to ensure new and continuing training availability on various GxP concepts (e.g. identify and purchase content from Third Party) -THE RIGHT STUFF: REQUIRED EXPERIENCE & QUALIFICATIONS - - - Undergraduate/Graduate degree in Chemical or Biological Engineering or life sciences with 5-8 years of document management experience in the biotech industry - - - - Experience setting up and managing validated, GxP Document Management and Training systems and interacting with vendors - - - Experience with Veeva Quality Vault - - - Understanding of document lifecycle management and how to apply to internal processes - - - Excellent knowledge of data integrity principles and how to apply in the management of the Doc Mgmt. and Training systems - - - Working knowledge of ICH guidance, regulatory guidance, and pharmaceutical organization guidance - - - Strong familiarity working in support of biologics or cell/gene therapy manufacturing process and technology - - - Ability to effectively communicate complex quality content to a range of audience in oral and written formats - - - Ability to flex between hands-on work (example, day to day quality support) and at the same time strategic work (example, planning/projecting future workload, proactive risk mitigations working cross functionally) - - - Knowledge of basic GMPs and regulatory requirements applicable to cell and gene therapy -PREFERRED EXPERIENCE & QUALIFICATIONS - - - Qualified trainer experience - - - Direct or indirect supervisory experience leading small teams -PAY RANGEThe combined pay range for the Senior Manager, GxP Document Management & Training Administration is from $136,000-$187,000. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.ABOUT CARGO THERAPEUTICSCARGO Therapeutics is engineering best-in-class CAR T-cell therapy to overcome resistance to cancer treatment and address barriers to access so that more patients may benefit from potentially curative therapies. CARGO is on a mission to outsmart cancer by advancing a new generation of best-in-class chimeric antigen receptor (CAR) T-cell therapies. Despite advances made by commercially available autologous CARs, these treatments are curative for fewer than half of all cancer patients. In addition, far too many patients are unable to access these potentially curative therapies due to other challenges, including manufacturing, supply constraints, slow turnaround time and reimbursement hurdles. The team at CARGO is intensely focused on pursuing novel solutions to achieve better cancer treatment outcomes and experiences. ---Our founders are pioneers and world experts in CAR T cell therapy, and we have built a team with experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. CARGO Therapeutics colleagues share a passion to help others thrive.--- We are tenacious in the relentless pursuit of our mission, and we innovate to change the game for the patients we serve. -Join us to help make a difference! -EEO & EMPLOYMENT ELIGIBILITY - - -CARGO Therapeutics, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. CARGO Therapeutics, Inc. also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requires of applicable law. - -CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date.--- This requirement is a condition of employment at CARGO Therapeutics, and it applies regardless of whether the position is located at a CARGO Therapeutics site or is fully remote.--- If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation. -

Keywords: CARGO-Therapeutics, San Mateo , SENIOR MANAGER, GXP DOCUMENT MANAGEMENT & TRAINING ADMINISTRATION, Executive , San Mateo, California