Biosense Webster Inc. is recruiting for a Manager,
Lifecycle Labeling, located in Irvine, California.
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.
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.
Manager, Lifecycle Labeling will be responsible for:
- 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
- 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
- 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
- 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
- A minimum of a Bachelor’s Degree is required, an
advanced degree is preferred
- Minimum of eight (8) years’ experience in
Operations, Engineering, NPD, Quality, Compliance, Regulatory and/or equivalent
with significant project and leadership accountabilities is required
- Demonstrated track record of Project Management
- Demonstrated track record of Leadership results is
- Project Management Professional (PMP)
Certification is preferred
- APICS, Green Belt and/or Black Belt
Certifications are preferred
- Demonstrated ability to lead a cross-functional
team, cross company, cross region team is 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 is preferred
- Demonstrated understanding of compliance
requirements for medical devices and labeling is preferred
- Demonstrated understanding of an end to end
Supply Chain, Global Surgery knowledge is preferred
- Six Sigma experience is preferred
- Design and Change Control experience is preferred
- Labeling Design and development process
knowledge is preferred
- Demonstrated leadership of projects across
quality systems, plants, and regions is preferred
- Demonstrated people management and talent
development is preferred
- Ability to travel up to 20%, domestic and
international is required
Ethicon Inc. (6045)Job Function
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