Manager, Document Management and Training to establish GxP compliant process and procedures for GxP document management and training. Must be able to work independently, and function as the company subject matter expert in relation to GxP document management and training practices.
Responsibilities include, but are not limited to:
• Develop and manage document control and training processes and systems for GxP activities in compliance with internal procedures and policies as well as regulatory requirements, and from perspective of a collaborative service provider.
• Assist in the design and implementation of Electronic Document Management System (EDMS) and Learning Management System (LMS).
• Act as the business process owner/admin supporting the maintenance and improvement to EDMS/ LMS.
• Develop, oversee, and execute document control procedures including the creation, routing, review, approval, distribution, periodic review and archiving of new and revised controlled documents.
• Establish and maintain records management system including secure storage, retrieval, retention and destruction for all internal and external sources.
• Develop and oversee GxP training program including the maintenance of training records, and periodic reporting of training compliance.
• Deliver training and/or site guidance on document, records management, and training processes.
• Review and approve both procedural and technical documents.
• Identify quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible and constructive manner.
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
• Identify and secure training and document management resources as needed.
• Define resource requirements; assign resources to tasks; manage assigned team.
• Other duties as assigned
Position Requirements & Experience:
• 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.
• Strong knowledge GxP regulations, SOPs and quality systems (Document Control, Training/Qualification, Change Control, Computer System Validation, 21CFRPart11) and guidance documents.
• Minimum of 2 years of management experience, in a document management role.
• Excellent writing, editing and document formatting skills.
• Works on multiple assignments in collaboration with various department system owners.
• Advanced skills with MS Office applications Word, Excel, as well as Adobe Acrobat.
• Knowledge of EDMS, and LMS work environments as well as paper-based document management and training systems; admin experience with Veeva Quality Docs 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 a fast-paced environment.
• Ability to work and make decisions independently and as part of a team.
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
• Strategic experience with senior leadership team level clients, strong decision making capability.
• LEAN/Six-Sigma training and risk management experience a bonus.
• Candidates must be authorized to work in the U.S.