Beacon Hill Pharma is currently hiring a Quality Management Systems Lead for a direct opportunity in the Lexington, MA area.
The Quality Management Systems Lead will be responsible for:
? Leading and executing activities related to procedural document development and training within R&D QA & Compliance
? This holistic view of the procedural document life cycle includes but is not limited to: quality facilitation of procedural document workgroups, harmonization of document subject areas where appropriate, authoring, reviewing, editing, appropriate documentation and archival of superseded material, and quality control of documents, reviewing regulatory requirements, identification and assignment of training in our client's Learning Management System, and training development and implementation.
? Under the direction of the head of the Quality Management System Standards, the person assuming this role will be expected to lead cross functional teams of Process Owners, Content Experts and functional area Subject Matter Experts, through an R&D document harmonization and biennial review process that is critical to our client meeting regulatory requirements and compliance commitments
? Expert user of the Controlled Document Management System (CDMS)
? Able to lead work flow facilitation of procedural documents within CDMS
? Minimum 10 years of procedural document development experience