Manager/Senior Manager, Document Management
ESCAPE Bio is a clinical stage, Precision Neurology biopharmaceutical company focused on the discovery and development of therapies to treat genetically defined, neurodegenerative diseases.
The Manager of Document Management (MDM) is responsible for managing the QA GxP Document Control System and GxP Training Program to assure compliance to quality objectives and regulatory requirements are met. Upon starting, the MDM will work with the Executive Director of Quality to develop control procedures, provide training and maintain Escape Bio Document Control System and GxP Training Program.
The MDM must be able to work independently as well as be an effective and engaged team member in a fast-paced environment with strong initiative and follow through. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
Roles and Responsibilities
- Develops, maintains and improves a Document Control and GxP Training program to ensure compliance with current GxPs
- Maintains Document Control system to ensure integrity and security of all documents containing data relevant to product quality and/or quality systems
- Maintains GxP documents and records (both hardcopy and electronic) as required by applicable regulations such that required documentation is retrievable and files are accurate, complete and well organized
- Collaborates with Functional Area Heads to set appropriate training objectives for employees and other individuals
- Implements and manages high quality learning programs that provide GxP compliance and Quality knowledge for staff
- Actively works on a diversity of documents with functional area exeperts to ensure adherence to processes, guidelines and/or regulatory requirements to enable timely archiving
- Evaluates the effectiveness of trainings, implementing modifications when necessary, and monitors training compliance for staff
- Performs the tracking and trend analysis of quality metrics
- Provides support for internal audits, suppliers audits and regulatory inspections as required
- Performs other duties as assigned
- Bachelor's degree in life sciences or engineering and 7 years of biopharmaceutical industry in a GxP environment
- Minimum of 5 years' Quality Assurance experience within Document Management and GxP Training
- Ability to write Standard Operating Procedures, work instructions, reports, etc.
- Proficient personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheet, graphics, etc. PowerPoint and/or other presentation software for the purposes of training
- Demonstrated ability to work independently and flexibly in a fast-paced, high growth environment
- Understanding of FDA & European regulatory requirements and guidelines
- Excellent technical writing skills and editing, formatting and organization skills
- Strong written and oral communication skills with crisp, clear and concise style
- Excellent attention to detail and customer service attitude
- Experience with Electronic Document Management System (EDMS) and e-Learning Management System (LMS)
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks