Manager, Global QMS Programs

Summary:

This position has overall accountability for managing critical data elements within BMS's electronic Quality Management System (QMS) called Infinity and will lead the development and management of QMS processes to ensure the system data is accurate and contemporaneous across the following workflows: Change Management, Investigations, Complaints, Audits, CAPAs, Stand Alone Actions and Notification-To-Management.

Responsibilities:

• Act as the QMS Data Lead for BMS's electronic QMS (Veeva Quality Vault branded as Infinity) across the following work flows: Change Management (Development & Commercial), Investigations, Action Management, Audits & Findings, Product Quality Complains and Notification-To-Management
• Primary owner of system data and processes to ensure that data is kept current
• Subject matter expert and business expert for workflows and system design
• Define and maintain data quality metrics to identify trends and take appropriate action
• Responsible for communication of system status/changes to business users
• Provide support from business perspective on internal/external system audits and regulatory agency inspections
• Owns policies, SOPs, work instructions, tools, templates and training modules for Infinity Data Quality processes
• Provides input and strategic direction for all Infinity enhancements including data and configurations changes
• Contributes to the development and maintenance of the continuous improvement plan for Infinity
• Work with end users to determine system enhancements for data management
• Ensures that current data integrity requirements are being maintained and satisfied
• Partners with IT to execute the strategy and build robust processes
• Reviews and approves GxP impact assessments for new releases/improvements
• Responsible for data quality and data integrity user requirements
• Reviews SDLC documentation including user/functional requirements, validation plans and summary reports

Qualifications:

• Minimum of a Bachelor's degree
• 5+ years' experience in the Biopharm/Pharmaceutical industry with cross-functional experience in one or more areas (i.e. research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT).
• Knowledge of health authority regulations and practical experience applying regulations in change control, investigations, complaints and audits
• Knowledge of compendia, cGxP requirements, FDA regulations and the ability to interpret and apply them
• Proven ability to understand complex processes/problems and propose alternate solutions (required based on need to design and implement global business processes and policies, which requires critical thinking and analysis skills)
• Ability to set priorities and deliver results without constant feedback/input from manager (required based on level of responsibility).
• Ability to identify, manage, and/or escalate issues and risks to timelines
• Customer and partner focus, including the ability to listen to and incorporate feedback (as appropriate) from key stakeholders (required to ensure completeness and robustness of processes and ensures effective adoption of processes)
• Ability to influence, initiate, and manage change
• Organization awareness and ability to work well cross-functionally with R&D, Regulatory Affairs, Global Engineering, etc. (required as these are key stakeholders and partners in the development and implementation of global processes and policies)
• Experience with Veeva Quality Vault a plus
• Strong verbal and written communication skills
• Project management skills