Manager, Document Control and Training

Company: Page Mechanical Group, Inc.
Location: Boston
Posted on: May 24, 2025

Job Description:

-JOB TITLE: Manager/Sr. Manager, Documentation and TrainingREPORTS TO: Associate Director, Quality Systems DATE PREPARED: May 5, 2025JOB SUMMARY:The Documentation and Training Manager is responsible for the development and administration of the GxP document control and training programs, ensuring compliance with relevant regulations and company standards. This role manages processes associated with the creation, storage, archiving, indexing, scanning,and classifying of GxP documents and records. This role is also responsible for designing, creating, delivering, and managing learning solutions for AVEO, managing employee curricula, and ensuring that Employee Training records are maintained in a compliant manner to support audit and inspection readiness.PRINCIPAL DUTIES:Essential Document Control responsibilities include: -Manage the daily functions of the Veeva QualityDocs (QD) system including document change controls, document review requests, and resolve documentation issues. -Serve as a resource for GxP staff on document management procedures and technology. -Collaborate with cross-functional groups to assess their document management needs and provide guidance on best practices. -Ensure compliance with SOP creation, revision, and biennial reviews, including the timely revision and distribution of documentation to the appropriate users. -Collaborate with cross-functional teams to align documentation and training with operational needs, ensuring that the quality of documentation and other content complies with approved document management procedures. -Facilitate GxP document and record lifecycle management, including storage and retention, disposition of records, and document retrieval in accordance with regulations, best practices, and corporate policies and procedures. -Lead inspection readiness initiatives related to Document Control. -Fulfill inspection support roles during regulatory inspections.Essential Training Administration responsibilities include: -Serve as System Administrator of the Veeva learning management system and work in conjunction with IT Representatives to maintain the System in a validated state. -Modify users and user permissions in Veeva upon user completion of required training, and in accordance with administrative procedures. -Oversee the creation, implementation, and modification of training curricula for GxP staff. -Coordinate with Functional Area Management to determine training needs, issue training solutions, and monitor training completion. -Ensure that comprehensive evidence of training completion is documented, filed, and readily available. -Establish training system KPIs and create system reports to monitor training compliance and training program effectiveness. -Collaborate with HR to ensure that CVs and JDs are obtained, and are maintained in a current, consistent, and compliant format for all GxP staff. -Manage various course design projects and collaborate with process owners and Subject Matter Experts to create and update content, as needed. -Deliver GxP training in a variety of formats including classroom, web-based, and blended learning. -Lead inspection readiness initiatives related to the training program. -Fulfill inspection support roles during regulatory inspections.REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS): -BS/BA or equivalent experience. -5+ years' combined experience in GxP Document Control and GxP Training supporting the biotech/pharmaceutical industries. -Strong knowledge of document management and learning management system processes and technology. -Proven experience in the delivery of training with excellent presentation, public speaking, and facilitation skills. -Excellent organizational, interpersonal, written and verbal communication skills. -Ability to demonstrate flexibility when dealing with changing priorities. -Extremely high level of professionalism and superior attention to detail. -Ability to interface and interact with internal and external collaborators at all levels. -Able to demonstrate a sense of initiative and ownership, including ability to carry out responsibilities with minimal to no supervision. -Ability to work in a team or independently in a multi-disciplinary team environment. -Demonstrated working knowledge of GCP, ICH guidelines, and global regulations as they pertain to Document Control and Training.About AVEOAVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
#J-18808-Ljbffr

Keywords: Page Mechanical Group, Inc., Somerville , Manager, Document Control and Training, Executive , Boston, Massachusetts