Quality Transformation Lead

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week

Who We Are:

At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun.

A name started our story. How will yours help write our future?

There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

The 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 work streams locally/globally and may work across multiple work streams.

* 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 Requirements

5%:
Up to 13 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or…