Associate Director, Business System Labeling Mgt. - Regulatory Affairs

You will bring the technical aptitude to own GxP business systems from requirements through release and hyper care, and the judgment to turn complex business needs into clear direction for Business Analysts, IT partners, and users.

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 monitoring 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.

Required Experience and Skills

• Requires 10+ years of experience in Pharmaceutical Regulatory Affairs Operations, including demonstrated end-to-end ownership and management of GxP business systems (system lifecycle, release management, change control, and operational support), with applied knowledge of SDLC.
• Labeling Process and Systems Digital Enablement experience strongly preferred.
• BS/BA in science, engineering, IT or related discipline with functional working experience in System Development/Management within GxP regulated areas preferred.
• 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.
• The ability to be flexible and handle multiple tasks well, under pressure that span Global Time zones.
• 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.

Required Skills

• Audit Readiness
• Business Requirements Management
• Business Systems Management
• GxP Regulations
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Labeling
• Regulatory Operations
• System Development Life Cycle (SDLC) Documentation
• Systems Development Lifecycle (SDLC)

Preferred Skills

• Business Analysis
• Change Control Management
• Process Improvement Initiatives
• Root Cause Analysis (RCA)
• Technical Documentation Management