This position is responsible for facilitating site procedural documents across areas of the QMS Framework and in association with electronic systems that support maintaining the QMS. This includes, but not limited, to document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement. Responsible for compliance assessment of procedural documents against Global Procedures and Policies Maintain a contemporary knowledge of current industry trends, standards and methodologies as it relates to quality systems and document management. Serves as the site Subject Matter Expert for procedures and their QMS and provides cross site support for a variety of different document management systems and process. Support strategic initiatives and continuous improvement projects related to QMS Synthesize feedback from SMEs/procedural document teams to identify and resolve issues in order to accurately document current and future processes May be required to effectively manage projects, escalate issues as necessary and identify/meet key milestones Work with guidance to manage the development of site procedural documents and, seek input as needed May be required to be a representative for global document management initiatives and projects Support site inspections and audits Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies Collect metrics to identify trends and take appropriate action Responsible for communication of procedural document status to businesses Maybe required to support the implementation and/or maintenance of additional QA Systems, which may include (but is not limited to) Documentation, Change Control, Quality Risk Management, Product Quality Complaints and Annual Product Quality Reviews Support the completion of investigation/CAPA activities as required Supporting People with Disabilities Minimum of a bachelor's degree 3+ years' experience in the BioPharm/Pharmaceutical/Cell Therapy industry. Cross-functional experience in one or more areas (i.e. research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT) is preferred Experience with demonstrated knowledge in quality and/or compliance discipline with in-depth knowledge of cGMP requirements and global health authorities' regulations Experience/Knowledge: In depth knowledge of cGMP requirements and global health authority regulations with ability to interpret, apply and implement. Experience in negotiating and influencing skills in a matrixed organization. High level of competency in procedural document writing including the appropriate use of grammar, syntax and organization of ideas Demonstrated ability to work independently with oversight from manager. Ability to identify, manage, and/or escalate issues and risks to timelines. Fluent in English, with proven professional working proficiency in English for reading, writing and speaking.