Associate Director, Global QMS Programs

The core responsibility of this position is overall business ownership of BMS's electronic QMS (Infinity) and will identify, prioritize and manage the execution of continuous improvement opportunities, ongoing system management and data governance across the following workflows: Change Management, Investigations, Complaints, Audits, CAPAs, Stand Alone Actions and Notification-To-Management.

• Acts as business owner of BMS's electronic QMS (Veeva Quality Vault branded as Infinity) including the following work flows: Change Management (Development & Commercial), Investigations, Action Management, Audits & Findings, Product Quality Complains and Notification-To-Management
o Subject matter expert and business expert for workflows and system design
o Primary owner of system data
o Define and maintain system health metrics to identify trends and take appropriate action
o Responsible for communication of system status/changes to business users
o Acts as main point of contact from the business perspective for issue escalation including potential system outages
o Overall responsibility for issue management/resolution for Infinity related quality events
o Provide support from business perspective on internal/external system audits and regulatory agency inspections
o Responsible for business continuity documentation and processes to avoid supply dispruptions
o Owns policies, SOPs, work instructions, tools, templates and training modules for Infinity processes
• Acts as Global Quality business lead for enhancements/improvements
o Provides input and strategic direction for all Infinity enhancements including data and configurations changes
o Develops and maintain a continuous improvement plan for Infinity
o Partners with IT to exexute the strategy
o Reviews and approves GxP impact assessments for new releases/improvements
o Responsible for user requirements
o Reviews and approves SDLC documentation including user/functional requirements, validation plans and summary reports
o Responsible for development and execution of User Acceptance Testing

Qualifications:

• Minimum of a Bachelor's degree
• 8+ 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).
• Subject matter expertise in 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)
• OPEX/Lean Six Sigma experience preferred
• Experience with Veeva Quality Vault a plus
• Strong verbal and written communication skills
• Project management skills