Cord Blood Validation & Quality Systems Manager

New York Blood Center • Long Island City, NY 11101

Posted 2 weeks ago

Job Description

Overview

At New York Blood Center, one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development. Join us as we work towards meeting and exceeding the growing needs of our diverse communities, further our lifesaving strategic goals in a rapidly changing environment, and expand our impact on the local, national, and global communities we serve.

Responsibilities

As a key member of our Cord Blood Program you will manage all validation and quality system activities, while overseeing GMP system documentation/SOPs related to the NCBP quality system(s), and providing procedural oversight/hands-on assistance during performance of annual SOP reviews.

Responsibilities include:

* Preparing/reviewing SOPs for Cord Blood Validation and Quality System

* Creating/updating validation templates and supervising/editing all specification, planning, qualification and reporting documents associated with such GMP systems

* Handling the logistics of change management operations for GMP systems (IT and production processes), including creation/updates to change management documentation

* Participating in all FDA-regulated audit activities and responses

* Maintaining and enhancing document management and control systems for Cord Blood SOPs, validation and quality systems

* Training staff on all validation and quality system SOPs

* Investigating, procuring and implementing software package(s) to better facilitate GMP handling of validation, document control, and Quality System for Cord Blood

* Performing other management related tasks as needed

Qualifications

To qualify, you must have a Bachelor's Degree and 10 years of relevant experience, or a Master's Degree and 7 years of experience, along with knowledge and expertise to control all Validation and Quality System activities within FDA requirements. The ability to balance Cord Blood validation and quality system goals/objectives while maintaining awareness of underlying regulatory concerns and best practices will be expected, as will superior leadership skills, and the ability to evaluate/investigate errors and their causes. cGMP Validation and Quality System experience, along with Software Quality Engineering and Six Sigma experience/certification are preferred. PC proficiency (Word/Excel/Outlook), and strong oral/written communication, analytical, problem solving and interpersonal skills are essential.

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