Associate Director, IPI Data Readiness

Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. The Integrated Product Information for Change Control (IPI) program will deliver transformational change to Merck's enterprise quality and operations functions, significantly enabled by implementation of a Product Lifecycle Management (PLM) platform. The IPI Specification Data Readiness Lead will work with the IPI team to develop and execute processes to migrate and cleanse the specification data required to support the IPI platform. This person will work in a highly matrixed environment working with many stakeholders from different functional areas, External Manufacturing, and all internal sites. Primary focus will be to lead the team of site and functional group IPI data resources to locate all applicable material specifications, cleanse those specifications in source systems when appropriate, construct specification data when required, and then perform verification after data migration. Additionally, this person will be responsible authoring IPI Data Standards for critical, GMP data elements, and support the development of a Data Governance process for post-go-live sustainment of specification data quality. The Specification Data Lead will: Lead a team of site data subject matter experts to identify local/site-based specification data and documents, construct or migrate that data in a Data Stewardship Platform (DSP), and perform verification of data migration.  Participate as vital member of data readiness team during data construction, migration, and testing Assist in functional system testing as required Work with subject matter experts and change execution management (CEM) on stakeholder management, change impacts, and training needs Work with other functions (e.g., COMET) to gain sponsorship for, select a platform, design and build a data governance platform for the enterprise that includes IPI. Author global system/process procedures and documentation to support data management and governance after go-live Assist Capability work streams as required Support design and build of additional specification types based on release functionality progression Qualifications Education Minimum Requirement: Bachelors degree in Engineering, Science, Business or Information Technology/Systems Required Experience and Skills: A minimum of 10 years of experience in operational roles (e.g. Production, Technology, Supply Chain, Quality) in a regulated healthcare industry, either medical device or pharmaceutical. Experience with multiple areas of product and material (e.g., packaging component) specification, analytical methods, labeling, etc. Experience with change control. Demonstrated strength in interpersonal relations and collaboration to effectively work across functions, regions and business units. Demonstrated experience in leading and supporting successful Business Process Improvement initiatives. Excellent communication and influencing skills. Creative/innovative mindset, with demonstrated ability to "think outside the box". Strong project management skills, inclusive of effective meeting facilitation and presentation skills, with a track record of successful execution.  Knowledge of the major Quality Management Systems (e.g. Change Control) and the associated cGMP Regulations Preferred Experience and Skills: Involvement in complex process improvement programs utilizing LEAN/Six Sigma methodologies to design and improve processes that deliver business strategies and performance objectives. Knowledge or experience with enterprise platforms, for example - TrackWise, SAP ERP, PLM (Product Lifecycle Management), LIMS. Experience with 21 CFR Part 11-related projects and IT SDLC (System Development Lifecycle). ID: QUA008280
Salary Range: NA
Minimum Qualification
11 - 15 years

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