Operational Excellence Lead

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace. Approximately 200 medically necessary drugs are on the U.S. Food and Drug Administration's shortage list. Manufacturing challenges and predatory pricing are both the cause and result.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Led by an experienced team of health care and pharmaceutical industry leaders.

Today, more than 50 health systems have joined Civica. They represent over 1,200 hospitals and over 30 percent of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines.

Civica is improving patient outcomes and reducing healthcare costs by making strides to ensure patients and their needs come first and that essential generic medications are accessible and affordable. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”

Civica is launching a subsidiary to enter the Outpatient pharmacy market partnering with Blue Cross Blue Shield with the goal of reducing drug prices, especially high-cost generic drugs where market forces are not working to control drug costs.

To find out more about how Civica's innovative model is directly impacting patient care, click below to read a recent article from the New England Journal of Medicine.

https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189

Intro to Civica

https://vimeo.com/646267406

The Operational Excellence Lead will assist Operations and Management to formulate, implement and maintain an Operational Excellence program which includes Strategic Planning, Lean Manufacturing and Six Sigma for the Civica manufacturing plant located in Petersburg VA.

The incumbent will:

Plan and direct Operational Excellence policies
Directs all aspects of Manufacturing Support
Partner with the Supply Chain, Quality and R&D group to achieve goals and objectives

Duties and Responsibilities:

• Develop an Operational Excellence strategy for Civica Petersburg, VA site and assure alignment with Civica Values
• Provide advice and assistance to Process Owners, Lean Improvement Teams, and individuals in the area of lean tools, change management, waste elimination, and customer driven improvement
• Develop Lean Six Sigma Green Belt/Black Belt Certification Training
• Coach and mentor Black Belts and other Lean Six Sigma practitioners in developing improvement strategies and using the Lean Six Sigma tools in-line with problem complexity
• Develop training and education strategies and tools to ensure lean six sigma expertise: training and best practice sharing sessions
• Partner with Manufacturing, Engineering, Quality and Product Development in assuring robust processes
• Develop and implement proactive, strategically aligned manufacturing/system support processes for all manufacturing activities that provide for successfully achieving aggressive manufacturing goals and objectives.
• Direct and oversee required MFG support and troubleshooting activities designed to resolve product/process quality issues and improve manufacturing robustness and cost efficiency. These activities cover all Site manufacturing and as applicable, contract vendor sites or raw material supplier sites.
• Provide the necessary technical management expertise and provide effective communication for product enhancements, troubleshooting, quality improvements, design modification, packaging engineering and system support in both intra- and inter-departmental team format.
• Work in an ethical manner both in individual and team efforts to fully address internal customer quality expectation issues.

Primary external customer is the regulatory agencies and markets. Customer regulatory, technical, product quality issues and expectations are inputs. The incumbent directs the resolution of the technical issues in a team function with resources from Manufacturing, Engineering, Quality Assurance and, Manufacturing

• Internal customers include Operations (Compounding, Fill Areas, Sterilization, Packaging and Materials Management, Global Supply Chain, Maintenance & Engineering and any new processes).
• The incumbent is also expected to be skilled in his/her ability to coach subordinates in developing, refining and enhancing their problem solving skills and teamwork skills.
• The incumbent must identify, staff and resolve the highest priority projects to meet customer needs while maximizing resource utilization.
• The incumbent must communicate sensitive and complex information both to persuade upper management and to promote action orientation and strategic thinking within the organization.
• Re-engineering and change management requirements must meet strict compliance standards while providing long term business impact.
• The incumbent has direct impact on profitability by the team interactions and support the department provides to Manufacturing, and Maintenance & Engineering.
• The incumbent resolves a broad range of problems which require continuous adaptation of knowledge and solutions to new situations which have no precedent.
• The incumbent mentors and models ethical action/behavior for PS Biotech by serving as a constant example for the Vision and demonstrates a high level of value and integrity.

Qualifications

• The incumbent must have a background in medical/pharmaceutical manufacturing and high level of proficiency in analyses of complex engineering/science problems.
• The incumbent must have strong managerial skills and demonstrated proficiency in team building within his/her team and across functions.
• This incumbent must have a BS degree and 7+ years in engineering or science with major experience in Manufacturing or equivalent combination of education and experience.
• This incumbent must have experience implementing Lean Six Sigma tools and strategies in a manufacturing environment
• Experience in key management role in a manufacturing site
• History of excellence performance
• Knowledge of Lean Six Sigma Tools and DMAIC problem solving approaches
• Experience and skills in driving strategic change
• Proven ability to interact with multiple levels of the organization
• Must have demonstrated ability to identify and motivate people, drive change; possess and instill a sense of urgency of staff; ability to find non-traditional ways of problem solving to meet the changing business needs, and possess good discipline in Milestone management/achieving objectives.
• Black Belt Trained / Certified preferred
• Strong analytical/problem solving skills
• High degree of customer sensitivity/acumen
• Outstanding communication and team leadership skills
• Demonstrated cross functional project leadership
• Demonstrated ability to independently develop, manage and implement aggressive project plans
• Demonstrated history of top performance
• Demonstrates potential to take on greater responsibility in the organization or possesses exceptional knowledge in statistical analysis

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