Business System Management Associate Director

Key Responsibilities

• Manage and lead Business Analysts for complex data analytics application
• Lead System Development, Maintenance, Enhancement and System Monitoring related initiatives
• Serve as a liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business Requirements and ensuring the system is aligned to meet the business needs
• Facilitate System Operations Mtgs including discussions to resolve issues and manage competing priorities utilizing proper escalation pathways to ensure limited impact to delivery timelines for workstream activities
• Lead the development of User facing System Resources ensuring supporting materials remain aligned with the current system version
• Work collaboratively with stakeholders in Global Labeling, System Support Team, IT and Learning & Development organizations to meet required delivery timelines associated with User Resources
• Lead System Releases in collaboration with IT Business Partners including activities relating to Requirements Gathering, Documentation, Testing, Implementation, Deployment and Hypercare phases
• Facilitate and oversee the System Support Model for systems within remit including: Monitor user support cases, ensuring thorough root cause investigations are conducted, CAPAs are detailed and closed effectively and communication is consistently done to reduce instances of recurrence
• Identify and design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team and End Users
• Conduct System Administrator activities supporting the alignment of the Global organizational processes with the System Capability cross-functionally and cross-regionally
• Facilitate System Specific Global User Group Forums, Release/System Communication authoring and Program Updates, as requested

Requirements

• BS/BA in science, engineering, IT or related discipline with functional working experience in System Development/Management within GxP regulated areas preferred
• Requires 10+ years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and Digital Enablement experience strongly preferred, and applied knowledge of SDLC and IT System/Business System Management
• Candidate must be proficient with IT system and business process support, preferably in the Regulatory or Labeling Management space with general understanding of Label Update process
• Must have experience with audit/inspection facing support for GxP systems and ability to communicate complex concepts in high pressure situations
• Analytical and process minded with a short learning curve for systems and processes to drive results based on specified objectives
• Demonstrates strong leadership and problem-solving skills and ability to gather relevant facts and distill information
• Effortlessly works in a collaborative manner with cross-functional and cross-regional users and stakeholders while building strong working relationships
• Effective communication skills (verbal and written)
• Ability to work cooperatively with others and provide significant contributions as a member of a team in addition to serving in a leadership capacity
• Strong organizational skills
• Demonstrates strong attention to detail
• Process-oriented and proficient with GxP (GMP) requirements with experience working in a highly regulated industry
• Experience with business process mapping and system design for workflow management is an asset
• Strong aptitude for authoring Technical Guidance documentation such as User Guidance and Standard Operating Procedures (SOP) and change control management is required
• Good understanding of SDLC Documentation requirements and processes pertaining to system management for GxP/GMP applications