Manager/Sr. Manager, Training and Doc Control Support Systems

Responsibilities

• Lead Document Control compliance and process improvement efforts
• Manage, plan, and coordinate document control activities and processes
• Manage documentation by processing, formatting, issuing the documents for training, and making it effective accurately
• Review Document Change Controls to ensure proper revision control of records and closure
• Manage document periodic review process and coordinate with the stakeholders on its completion
• Execute user test scripts for the electronic document management system during changes to the systems
• Manage Learner Roles, curriculums, and training requirements in the Learning Management System (Veeva Training)
• Support onsite audits and/or in any regulatory inspections
• Perform other projects related to improvement of quality systems as needed and required by management

Qualifications

• Bachelor’s degree or higher
• Minimum 5-10 years of experience in a quality assurance role in the pharmaceutical industry required
• Experience with EDMS and LMS systems, preferably Veeva Quality Docs and Veeva Training
• Excellent knowledge and understanding of applicable GxP regulations
• Familiarity with Microsoft Office Suite, Adobe Pro, etc.
• Able to work in a fast-paced environment with excellent multi-tasking skills
• Must have attention to detail
• Works with minimal supervision
• Must have effective technical writing skills
• Requires excellent organizational, interpersonal, and communications skills
• Exhibits professional behavior and is aware of the importance of teamwork within the assigned department