Posting Title Associate Director, Operational Excellence

Job ID	116852BR
Division	Over The Counter
Business Unit	Over The Counter
Country	USA
Work Location	Parsippany, NJ
Company/Legal Entity	Novartis Consumer Health
Functional Area	Production
Job Type	Full Time
Employment Type	Regular
Job Description	Position Summary Lead effective deployment of continuous improvement methodology across the Novartis OTC manufacturing network. Initial focus will be in facilitating the implementation of Continued Process Verification for all Novartis OTC products and supporting sites in reaching state of control for all manufacturing processes. Focus will evolve with organizational performance to cover improvement projects in all aspects of operation. Key Responsibilities • Develop and maintain Global Operating Discipline related to Continuous Process Verification (CPV) • Coach site teams in defining tactical plans for the implementation of CPV • Mentor site teams in projects to improve process robustness, root cause analysis and CAPA effectiveness • Process Validation and Transfers: o Statistical analysis of process validation data for demonstrating validity and equivalence o Contribute to risk assessments, e.g. FMEA or risk matrix. o Planning and evaluation of Design of Experiments (DoEs) in the frame of the Novartis Quality by Design validation strategy • Trending analysis in the frame of Continuous Process Verification (CPV) o Implementation and application of Statistical Process Control principles, e.g. control charts, and other pattern recognition techniques. o Facilitate and enable (multivariate) process monitoring and control principles, e.g. by Multivariate Data Analysis (MVDA). o Review of stability data and definition of Internal Release Limits (IRL). • Support critical root cause investigation (e.g. observation of Out Of Spec (OOS) and other deviations): o Support the analysis of complex data sets to facilitate Rapid Root Cause Investigation (rRCI) o Provide meaningful statistical conclusions • Develop educational plan and teach Six Sigma methodology to site teams leveraging Novartis Innovation, Quality and Productivity (IQP) program • Enable Process improvement initiatives in alignment with operational excellence organization and methodologies (e.g. IQP, Six Sigma, Lean Manufacturing): o Capability and stability assessments o Hypothesis testing o Models for facilitating process improvements, e.g. DoE, MVDA, Computational Fluid Dynamics (CFD), multi linear curve fitting • Stay current with external environment and continuously improve internal SOP accordingly • Function as a SME representing OTC in cross functional/divisional teams (ie partner with Quality in the upkeep of Quality Manual modules) • Form and facilitate community of practice to ensure continuous learning across sites
Minimum requirements	Education • Bachelors Degree in Statistics, Mathematics, or related engineering or science discipline. Masters or Phd desirable Experience • 10 years related experience in a Pharma/GMP regulated manufacturing environment with deep process understanding • Proven experience with applied statistics, including DoEs and multivariate data analysis • Experience with SAS, R, Minitab, SIMCA-P+, Modde, JMP, and/or SPSS is a plus. • Six Sigma Black Belt with demonstrated success in robust Pharma industry process projects. MBB preferred • Experience implementing CPV globally • Experience deploying root cause analysis and CAPA effectiveness methodology • Experience coaching/teaching and facilitating teams • Experience leading cross functional teams Must be able to travel 30%--domestic and international Novartis Consumer Health, Inc. is an EEO/AA employer M/F/D/V.