This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week Job SummaryThe Quality Transformation Lead will lead transformative global efficiency programs. This position will evaluate process capability within quality, identify waste/redundancy, create business cases to change, and lead the development/deployment of the improvement. Individuals in this position will be change agents that influence enterprise operating models and standards.
Essential Duties and Responsibilities- Development of current-state process maps, problem definition, and measurable improvements.
- Conduct stakeholder analysis and formulate communication plans to create a shared need.
- Assemble a tangible business case and seek funding through standard review process.
- Develop and maintain a multi-phased project and resource plan.
- Present program status updates to executive champions.
- Lead a cross-functional process design including risk mitigation, KPI's, user requirements/user acceptance criteria, and standard work.
- Integrate process into existing QMS standards.
- Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
- Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
- Measure project plans, budget, and resource allocation to deliver solution as expected.
- Create and release training that supports the solution.
- Establish a support network and governance structure to implement and maintain the solution.
- Identify and coordinate with related process changes across the organization to maintain standard enterprise solutions.
- Execute seamless hand-offs of newly designed process with global process owners and supporting teams.
- All other duties as required.
Additional Responsibilities- Works independently with minimal guidance.
- Develops technical knowledge, requires working knowledge and experience in project management.
- Manages single workstreams locally/globally and may work across multiple workstreams.
- Maintain clear communication paths with stakeholders.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
- Exhibits regular, reliable, punctual and predictable attendance.
Education- Bachelor's Degree Science related field, Chemistry, Biology, engineering required or equivalent experience
Work Experience- Minimum 5 years' in Contrinuous Improvement / Operational Excellence.
- Minimum of 5 years' experience in pharmaceutical or medical device environment; minimum 2 years' experience in a Quality role.
Preferred Knowledge, Skills and Abilities- Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
- Knowledge of ISO 9001:2015, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP, MDR.
- Work independently and in a team environment. Experience navigating matrix/global organizations.
- Demonstrated enterprise-level deployment experience.
- Ability to convey innovativeness in a clear/structured way when proposing alternate solutions for process improvement.
- Leverage data to identify root cause and to measure improvements.
- Experience with SAP, data analytics dashboards, data governance, process automation, and Digital QMS is preferred.
License and Certifications- Lean Six Sigma Green Belt or Black Belt certification preferred.
- PMP certification preferred.
- ASQ CQE certification desirable.
Travel Requirements5%: Up to 13 business days per year
Physical RequirementsSedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
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