Manager, Document Control and Training

Responsibilities

• Supports Quality Metric reporting at QMS Boards and Management Review meetings
• Serves as a Subject Matter Expert in electronic learning and document management systems, managing user support, system improvements, and data
• Oversees and ensures periodic reviews of controlled documents (such as Policy, SOP and Work Instructions) are performed and documented per SOP by working with the GXP business areas
• Ensures compliance with legal and regulatory standards for document storage and retention
• Oversees company training program, partnering with GXP and Non GXP areas, including improving onboarding training experience and process with new employees
• Oversees, creates, implements and manages job specific curriculum/training matrix for GXP functional areas by partnering with GXP Business areas on curriculum training matrix
• Supports inspection readiness activities and regulatory inspections on site and remotely

Qualifications

• Bachelor’s degree in science or related field with 8 - 10+ years of GxP Quality experience in life sciences industry or equivalent experience
• Demonstrated experience in managing pharmaceutical quality systems such as Document Management, Training, Quality Metrics reporting
• Experienced in electronic Quality Management and Training Management Systems
• Excellent communication and time management skills
• Good presentation, verbal and written communication skills
• Ability to project manage and lead cross-functional teams in a fast-paced environment
• Demonstrated experience in leading, managing and improving pharmaceutical quality systems
• Strong leadership, technical, management, problem solving and project management skills