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Senior Manager, Product Quality Management

4 months ago

Titusville, United States Johnson & Johnson Full time
Job Description

Johnson & Johnson is currently recruiting for a Senior Manager, Product Quality Management (PQM)-Excellence Lead This position can be performed remotely in the North America or EMEA regions. Remote work may be considered on a case-by-case basis and if approved by the business.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

Key Responsibilities:

· Have accountability for developing and executing Product Quality Management (PQM) Technology roadmap to support operational agility and efficiency.

o Develop, Manage, and communicate the PQM Technology Roadmap. Part of the communication will be internal to PQM, and part will be to Innovative Medicine Quality Digital, Data and Analytics (DD&A) group.

o Establish/update/manage LRFP and yearly PQM budget, capital funding (aCAR) development, and business case development related to roadmap execution.

o Be the project manager for PQM technology roadmap projects and many aCAR processes.

o Translate PQM application needs to user stories and user requirements for implementation by J&J Technology Business Analyst. Maintain a cadence of obtain requirements from functional areas within PQM.

o Lead deployment/change management within PQM for deployment of new application or updates to existing applications.

· Be direct responsible Quality partner to Therapeutics Development & Supply (TDS) organization for electronic Reporting related activities.

o Collaborate with R&D on unified data model to allow for improved and streamlined dossier authoring, including automation of technical reports such as specification, criticality analysis, stability reports, etc.

o Critical participant in the technical translation of business to system requirements and understanding of the unified data model connecting data fields across the different electronic Reporting modules with specific focus on quality topics.

o Post implementation develop user stories to resolve technical issues.

o Support onboarding of users into digital applications.

o Work with R&D and application vendor to determine user stories that improve automation for PQM specific interests within.

· Establish/adapt quality system/process/procedures to enable implementation of advanced analytics applications in product development/commercial manufacturing such as PAT, continuous manufacturing, real time release.