The Manager, Quality Management Systems is responsible for supporting the development and implementation of the electronic and physical record documentation and learning management systems and the development of related strategies, processes and procedures that ensure compliance with established company and industry requirements.This position is additionally responsible for supporting the design, implementation, administration, and continuous improvement of the electronic document and learning management systems and the development of related procedures.The successful candidate is proficient in communication (written and verbal), is action-oriented and timeline focused and flexible in their work scheduling to meet the demands of a multi-product clinical phase pharmaceutical company that is transitioning to the commercial phase.PRIMARY JOB FUNCTIONS* Support the implementation, administration and maintenance of electronic and physical record documentation processes and systems, including:* Assist in the development and implementation of standards and procedures governing the electronic and physical record documentation system.* Develop procedures, work instructions, training materials/job aides describing electronic documentation system processes and use of the electronic Document Management System, including document development, coordination, review (routine and biennial), approval, implementation, distribution, change control, archival and retention.* Support development of procedures, work instructions, describing physical record documentation system processes, including physical record distribution, archival, retention and destruction.* Support the establishment and implementation of a global quality agreement process.* Collaborate with appropriate representatives to establish templates supporting quality agreement execution and for the maintenance and proper distribution of templates.* Establish and implement procedures describing the quality agreement process, including the initiation, review (routine and periodic), execution, distribution, archival and retention of agreements.* Support document coordinator related activities, as needed, including, but not limited to performing document control review/approval on documentation managed through the electronic document management system, distributing official documents to internal and external customers, monitoring and executing the document periodic review process.* Function as an electronic Document Management System Subject Matter Expert; provide support and guidance to internal customers and expertise on document technical writing and effective document content and design to authors, and conduct end-user electronic system training, as needed.* Support the implementation, administration and maintenance of training management processes and systems, including:* Assist in the development and implementation of standards and procedures governing the training management system.* Develop procedures, work instructions, training materials/job aides describing use of the electronic quality management system.* Support development of procedures, work instructions describing training management system processes, including training documentation and training record maintenance, qualification training, periodic and annual training review, qualified trainer program, etc.* Plan, organize, implement and control elements of the training system including developing courses, curriculums, and delivering training.* Support activities related to designing, developing and implementing global training content and curricula strategy.* Collaborate with trainers and subject matter experts to design, develop and update training materials using appropriate instructional design methodology.* Support the management of the training course catalog.
Ensure the course catalogue is adequately maintained.* Support training coordinator related activities, as needed, including, but not limited to receiving and processing of training requests, creation and modification of training profiles, training curriculums, training plans and training user groups, execution of periodic and annual training review processes, and identification of document training needs.* Report training information to internal and external customers, auditors and/or inspectors upon request.* Support system administration activities for the electronic Document Management and Learning Management Systems.* Support Quality Management Review, including data gathering, data review and presentation.* Support the development and implementation of a global Quality System.* Assist in developing and implementing processes, policies and procedures governing the global Quality System.* Identify opportunities for enhancing the overall Quality Management System programs, processes and systems and seek input on proposed strategies and/or processes to facilitate continuous program.* Support the implementation of electronic system enhancements through participation on electronic system validation projects, establishment and/or review of electronic system validation documentation and performance of verification/validation/qualification testing related to system changes, as needed.* Support internal and external audit and inspection activities through retrieval and provision of requested documents and data in a timely manner.* May conduct other Quality related duties, as assigned.* Bachelor’s Degree (BA/BS) with a minimum of 7 years of experience in a GMP regulated Biologics or Pharmaceutical environment.* In-depth knowledge and understanding of Quality Management System regulations and requirements, global quality standards and cGMPs relating to documentation, training and electronic systems, including electronic records and signatures.* Strong authorship and ability to communicate effectively across the entire Aadi organization on matters related to documentation and training management systems.
Able to prepare written communications with clarity and accuracy.* Must be able to work independently with ability to complete routine tasks with little or no supervision.* Able to respond to challenges and additional projects in an understanding, positive, and objective manner, adaptable to dynamic conditions, work practices, and project timelines.* Must be proficient in Microsoft Office (Excel, Word, Access, Power Point, Visio) and Adobe Professional software.OTHER REQUIREMENTS* This role can be performed remotely from a home office in the US