Manager, Documentation Systems And Services

Description:

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

The Manager, Documentation Systems & Services will manage the global Central Quality services team supporting documents and records management, document control, and the business-administration of the Electronic Document Management System (eDMS), Veeva Vault Quality Docs.

Reporting directly to the Associate Director, Documentation Systems & Services, this position will be responsible for: Building, structuring, and managing a cross-global team of contractors and/or full-time employees to support document management services requests, document control coordination requests, Vault Quality (eDMS) and Document Control business process general support, eDMS business-administration (user access management), lab notebook/log-book support and management, records/archiving management, and other projects as needed. As a leader within the Quality organization, the role will be responsible for defining, measuring, and reporting key performance metrics, setting priorities based on business objectives, managing a team or direct-reports, and cultivating a continuous-improvement quality culture.

The Manager, Documentation Systems & Services is a Subject Matter Expert (SME) and primary decision-maker representing Quality processes for Document Management and Vault Quality Docs (eDMS). The role will support integrations, change controls, deviations, CAPAs, and other projects in Central Quality Systems and Services as needed

• Building, structuring, and managing the global team supporting document coordination, service requests, records management, lab notebook and logbook issuance, eDMS user administration and training, and general Document Management/eDMS support/guidance.
• Establishing and maintaining positive relationships with managed services, contractors, vendors, and suppliers.
• Building strong, collaborative relationships with cross-functional teams to ensure adequate services are being provided and continuously enhanced.
• Managing global processes and training requirements for document changes, creation of new documents, obsoleting documents, records management, periodic review, and Vault Quality business administration/user access.
• Defining, monitoring, and reporting Key Performance Metrics to the Quality Leadership Team (QLT) related to volume, capacity, lead times, and performance in alignment with Central Quality business objectives.
• Effectively planning and defining priorities to team and driving all activities by effectively structuring team, delegating, and overseeing all activities to ensure deadlines, quality standards, and customer-expectations are met.
• Providing leadership and decision-making for customer queries, projects, process-deviations, change controls, and other matters in scope of responsibility.
• Managing direct reports including scheduling, PTO, timecards, performance evaluations, and disciplinary action as needed.
• Setting clear performance expectations for staff and effectively manage team to ensure expectations are being met. This involves supervision, coaching, strong communication, and continuous development.
• Overseeing deviations, CAPAs, and Change Controls in-scope of Documentation Services and continuously monitor process-trends. Providing coaching and oversite on root cause analysis, corrective and preventive actions, and other tasks as needed.
• Cultivating a strong quality culture and continuous improvement mindset across Document Management and Central Quality.
• Managing e-Room used for communication of key documents to CMO’s as required.