US-NJ, Global Head GDO Process & Standards Excellence 212996BR-MZ
Global Head GDO Process & Standards Excellence
Global Drug Development
East Hanover, NJ
Research & Development
Leads the Global Development Operations (GDO) Process & Standards Excellence group, ensuring GDO wide fit for purpose pro-cess management and optimization (standardization, quality and change management, training effectiveness), data governance, cross functional process-based compliance oversight, SOP governance and change management, and overall portfolio and project management of GDO wide process improvement projects to further enhance and optimize GDO s overall effectiveness.
1. Lead the GDO Process, Quality/Compliance Network
Drives process improvement projects using Lean/Six Sigma methodologies working with function sponsors and SME s.
Identifies process improvement opportunities and initiates projects.
Build and Create Compliance Network: Appropriate governance body structure to provide an unbiased neutral platform for compliance within the GDO organization
Manages overall GDO SOP governance and change management, serving as the lead GDO member of the GDD-wide Process and Training Governance Board.
Provides compliance oversight, gap analysis and best practice sharing for GDO.
Drives independent investigation of complex, cross-functional process based SOP deviations and quality incidents.
Implements process based compliance standards within GDO
Defines and implements key quality indicators (KQIs) applicable cross functionally
Assesses trends/patterns across multiple functions/divisions. Trending of clinical (non-vendor related) issues / audits captured in eIAR, AQWA, CFIT, etc. across functions/divisions
Build and Implement Process Improvement (6 Sigma trained group) to enhance GDO wide process health and mitigate risk.
Provide oversight and independent check of each GDO s function s maintenance of their function specific Quality Plans.
Assesses the effectiveness of processes and training through surveys and focus groups, and input from quality management, with an emphasis on cross-functional process dependencies
Supports training effectiveness and compliance through applicabilities management, compliance reporting, and other training support operations.
Ensures inspection readiness of GDO. Represent GDO(as needed) during Health Authority Inspection / Internal Systems Audits when appropriate. Develops and manages overall framework process for inspection readiness of the GDO functions.
Independently monitor KQIs (Key Quality Indicators) and related targets to ensure active implementation of applicable processes and regulations. Ensures that appropriate action are taken to address any deviation from target
Provide oversight on quality and compliance in conjunction with Clinical Operations QA Lead and Franchise QA Lead; ensure coordination of responses to audit issues at the GDO level
2. Leads the Data Governance Council Group:
Build Data Governance Team with business knowledge with singular focus on the needs of the data governance organization and its user community.
Drive centralization and standardization collaboratively with the GDO line functions to create more efficient processes and promote operational excellence as related to standards governance; Demonstrate high value to line functions and stakeholders as the GDO organization continues to evolve.
Manages end-to-end lifecycle governance process (review, approval, impact as-sessment, implementation policies) for CRF components and report outputs (owner-ship remains in the functions).
Coordinates process for standardized global templates with version control, life cycle management & exception process; including Protocol1, ICFs CSR, disease guidelines; across NVS (Ownership remains with divisions/LFs) as related to GDO deliverables.
Drive process for implementation of global standards governance along with decision making, proper escalation; ownership of metadata updates, communication and training of governance; single portal housing/linkages to current standards; (Standards updates remain in functions)
Proactively collaborate and execute in unison with existing PTO Info modeling and Data Governance group (legacy STRIDE).
3. Lead the GDO Process Improvement Project Management Office:
Create and lead a PMO managing the portfolio of specific GDO process improvement projects in alignment with GDD PMO and OpEx.
Initiate and execute process improvements projects in partnership with GDO func-tions by providing:
o Project management leadership and coordination of improvement projects across the GDO functions
o Creates Project Management Community and provides project management services for approved initiatives; determining appropriate resourcing (based on scope / timelines); maintaining initiative prioritization across GDO; provid-ing standard templates / charters / tools, securing subject matter experts (SMEs) support from the GDO (and as appropriate, GDD) line functions
o Conduct post-initiative Impact/productivity assessments (with KPIs/metrics)
o Serve as the central point of contact for the GDD Project Management Office (PMO), enabling transparency into GDO sponsored tier 1-32 / 3 projects, prioritization, status and resourcing.
4. Build the Teams and the Talent
Establish annual GDO Process and Standards Excellence Group objectives in line with PTO & GDO priorities and oversee hiring process to ensure talent continuity.
Develops high competence in the team with relevant process improvement method-ologies (Lean, Six Sigma) and external best practices.
Manage global team; Build a deep talent bench by driving top-level talent acquisition succession planning and development of associates across who are working to their full potential and to build a strong talent pipeline for Novartis.
Strengthen the organization by developing an excellence-oriented One Development culture, change management, high engagement, and fostering innovation, and building best-in-class teams that fully exploit Drug Development opportunities,
May deputize for Head, Process & Technology Optimization (PTO)
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Bachelor s degree required; MSc/PhD (or equivalent) in life science, computer science, statistics, mathematics, or business administration, preferred. Six Sigma/Lean and /or PMP / PMI certification highly desired
English written and spoken
15+ year s relevant industry experience including expert knowledge in clinical development, clinical trial methodology & operational design, quality & regulatory standards & policies and medical terminology.
10+ year s multi / cross functional international leadership experience. Strong team leadership skills and track record in enabling effective international collaboration
Considerable organizational awareness, including significant experience in matrix and high pressure environments
Strong technical and problem solving skills
Excellent interpersonal and communication skills, able to naturally bridge scientific and business participants;
Proven ability to effectively sponsor/lead major process improvement initiatives.
Outstanding verbal and written communications
Significant experience in problem-solving within the context of rapidly-changing priorities and external environments
Proven ability to organize, prioritize and work effectively in a constantly changing environment and motivate the team to do the same.
Extensive experience in change management and the implementation of complex systems. Expertise in project management
Experience with Health Authority inspections preferred
Ability to lead without authority and strong problem solving skills.
Ability to resolve issues with minimal supervision and understand when to escalate
Proven negotiation and conflict resolution skills
Proven ability to manage multiple individuals and teams simultaneously
Strong Project Management skills including, attention to detail, and usage of key project management tools and resource/budget management systems
Strong leadership, motivation skills with ability to influence without direct responsibility
Functional experience in operations, analytics and management reporting
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