Document Control Manager

Document Control Manager Rani Therapeutics - 3.0 Fremont, CA Job Details $139,409 - $190,000 a year 1 day ago Qualifications Procedural guides ISO standards

FDA 21 CFR

Part 11 Biomedical regulatory compliance Full Job Description

GENERAL INFORMATION

Position Title Document Control Manager Department Quality Reports To VP, Quality Assurance Purpose of the job The Document Control Manager is responsible for managing all document control activities for Rani Therapeutics. This includes the development, administration, maintenance and monitoring of the company's document control activities in accordance with

FDA/QSR/QMSR, ISO 13485

requirements and applicable international regulations. In addition, this position is responsible for administration and maintenance of a robust company-wide training system, providing personnel training, preparing for external audits/visits, procedure/form updates and supporting streamlining the QMS. Major Duties and Responsibilities Administer all aspects of the Arena PLM/QMS system for Rani Therapeutics Identify opportunities to improve PLM/QMS controls; collaborate with Arena representative to discuss and implement changes Interface with Rani Quality Engineering to document the assessment and/or Part 11 validation of system changes prior to implementation Develop, manage, and maintain document control and training processes and procedures in conformance to industry standards/requirements Co-develop Training Plans with functional management; implement and maintain company-wide QMS training system Coordinate review of ECOs for accuracy and completeness prior to routing; work with initiators to minimize rejections and withdrawals Coordinate on-boarding and routine training to Arena users Create and present trend analysis (e.g., ECO and Training Quality Metrics) on a routine basis Procure, organize and maintain a library of external documents (e.g., Standards) that are used in support of company activities/products Provide guidance and recommendations for adherence to Rani Therapeutics procedures based on regulatory requirements Prepare documentation and provide training for initiators of ECOs Evaluate and develop improved techniques and use of tools for the control of documents and quality records Provide backup support for supplier files and supplier approval list in accordance with the Supplier Management procedure Other duties/ activities may be necessary to support departmental or company goals Experience & Education 5 years' experience at a Document Control manager level in the Medical Device industry 10 years' experience in regulated industry with demonstrated quality system knowledge including 21 CFR Part 11, QMSR/21 CFR Part 820 (QSR) & ISO 13485 Experience developing documentation processes and procedures Individuals must have a hands-on approach Ability to work on multiple projects simultaneously Experience with related PDM systems desired (e.g. SolidWorks) College degree desired Skills and Specifications Ability to motivate and influence people Organizing, planning, and problem-solving skills Strong organizational and time management skills with high attention to detail Good interpersonal and communication skills Excellent computer skills Ability to work as a part of a team Ability to create and provide training