Sr. Manager, Lifecycle Labeling
Biosense Webster, Inc., is recognized worldwide as an industry leader in endocardial diagnostics and therapy. Guided by the needs of electrophysiologists and cardiologists, the company has pioneered innovative technological advancements ranging from the first deflectable tip catheter to today's most sophisticated three-dimensional cardiac mapping and navigation systems. Biosense Webster, Inc., combines leading-edge technology with a tradition of quality and responsiveness while partnering with the physician to optimize patient outcomes.Position Description:
Biosense Webster Inc. is recruiting for a Sr. Manager, Lifecycle Labeling, located in Irwindale, California.
Accountable for lifecycle labeling project portfolio management. Point person for lifecycle label change requests and accountable for end to end execution of labeling changes in support of artwork only changes. Support the labeling changes in support of business unit objectives and strategies, regulatory and compliance requirement changes and supply chain strategies. Key Responsibilities:
• Point person for business units in developing labeling strategies, project plans and executing project plans. Engaged with business units directly and represents labeling function.
• Lead the Lifecycle Labeling Project Portfolio Review Process which includes a cadence of obtaining project requests, participating in Business Unit Lifecycle team governance, and leading cross-functional team to review the projects’ business case, conduct risk analysis and develop recommendations for approval, priority and project change governance.
• Partner with Business Unit PM Director or PM Lifecycle Product Manager, Quality, Regulatory, Marketing associates for prioritization and execution strategies, this role will have a dotted line to the PM Director accountable for the business units being supported.
• Represent Lifecycle Labeling Portfolio recommendations to appropriate governance bodies for approval of recommendations. Ensure stakeholders understand outputs of all decisions and track project status.
• Maintain product label design and process knowledge for those platforms responsible.
• Represent Labeling in Change Review Board (CRB) or equivalent within local design change control process.
• Accountable for executing Design Change documentation and execution for label only changes.
• Responsible for leading collaboration for impact analysis, alignment on scope and changing label content with Regulatory, Clinical, Quality, R&D and FOD as required.
• Responsible for supervising internal and/or contracted associates to complete Design Change documentation and execution through the label change.
• Accountable for working with planning for phase in/phase out of changes considering commercial, quality or regulatory strategies and insuring implementation.
• Review and approve documents representing Labeling as outlined per local quality system procedures as appropriate.
• Lead projects as appropriate for unplanned event responses or planned changes. Accountable for integrating and coordinating impact analysis, response development, communications planning, and execution associated with unplanned events that impact continuity of quality supply.
• Develop & execute multi-generational project planning (MGPP) strategies to meet quality, compliance, delivery and cost goals.
• Lead and/or support CAPAs as required.
• Know & follow local Quality System policies & procedures
• Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments & for implementation of new policies & procedures. Complete required periodic re-training in areas such as safety and environmental.
• Follow all company safety policies & other safety precautions within work area. Promote safety to all associates that enter work area
• Ensure multi-project coordination of changes for assigned business units.
• Other responsibilities may be assigned & not all responsibilities listed may be assigned
• Be able to represent the Labeling COE as a site lead if assigned
• Manage direct reports which may include NPD leads, Labeling Analysts, Content Coordinators.
• Maintain business unit Qualifications
Education & Certifications:
Bachelors Degree required
Masters degree or M.B.A. preferred
Project Management Professional (PMP) Certification preferred
APICS certification preferred
Black Belt certification preferred
Green Belt certification preferred
Skills & Experience:
• Minimum of eight (8) years’ experience in Operations, Engineering, NPD, Quality, Compliance, Regulatory and/or equivalent with significant project and leadership accountabilities required
• Demonstrated track record of Project Management required
• Demonstrated track record of Leadership results required
• Demonstrated ability to lead a cross-functional team, cross company, cross region team preferred
• Demonstrated understanding of the Medical Device or equivalent regulated industry, Quality Systems and Change Control procedures would be preferred
• Experience in a New Product Development projects or Lifecycle Projects is preferred
• Technical Writing skills and experience preferred
• Demonstrated understanding of compliance requirements for medical devices and labeling preferred
• Demonstrated understanding of an end to end Supply Chain, Global Surgery knowledge is preferred
• Six Sigma experience preferred
• Design and Change Control experience preferred
• Labeling Design and development process knowledge preferred
• Demonstrated leadership of projects across quality systems, plants, and regions preferred
• Demonstrated people management and talent development preferred
• Ability to travel up to 20%, domestic and international requiredPrimary Location
Biosense Webster Inc. (6010)Job Function
Graphics/Technical WritingRequisition ID