Program Manager, Input Controls

Title    

Program Manager, Input Controls

About Us    

What do you envision for your future? At GE Healthcare, our vision involves looking at Healthcare in a completely new way. Focusing on earlier, pre-symptomatic disease detection and prevention, instead of late diagnosis. Helping clinicians access more information and intervene sooner with targeted treatments so their patients can leave longer, fuller lives.

We believe we can help make that happen – and we’d like you to be a part of our mission. As a global leader, GE can bring together the best in science, technology, business and human resources to redefine the frontiers of healthcare. Something remarkable happens when you bring together people who are driven to make a difference – they do.

---Your Life. Your career. Your purpose. Re-imagined---

GE Healthcare is committed to Quality and Compliance in every decision we make & every action we take, believing that this benefits patients, customers, and our business.

We support Quality and Compliance in all that we do through two fundamentals:
-The Spirit … the integrity of our products, processes and actions
-The Letter … the adherence to the rules to make sure our products and practices are in compliance with applicable laws and regulations.

Role Summary/Purpose    

GE Healthcare’s (GEHC’s) Quality Program Management team executes & validates assigned programs that support the GEHC Quality Management System (QMS). This Program Manager establishes processes and tools to maintain control of non-product software systems installed on desktop, servers and workstations throughout GEHC. This requires the coordination of business users in Service, Engineering, Supply Chain and IT.

Essential Responsibilities    

• Establish appropriate Input Controls for the introduction of new non-product software applications into the regulated environment. Assure the implementation of these input controls across affected functional departments in the GEHC business
• Implement appropriate processes and tools to manage and track the global inventory of GxP relevant non-product software systems as well as any functional changes to non-product software systems. Drive adoption across functional departments
• Drive and be accountable for operational excellence of assigned program(s), with duties including project planning,, feasibility analysis, cost benefit analysis, prioritization, resourcing, initiation, execution and closure for all project work related to the program, partnering with IT Program Manager, as required
• Establishing operation mechanisms for all projects. Clearly and concise communicate program status, issues, risks, plans, etc. to senior management
• Manage budgets and contracts associated with program(s) or initiative(s) as applicable
• Manage activities of business project team resources to support and deliver solutions relating to the program(s)
• Maintain effective working relationships with peers and vendors to seamlessly integrate the program area into the overall strategic objectives and activities of the organization
• Responsible for the business process and data quality of the assigned program(s), working with the business owners of this data
• Coordinates program support activities, including the development of internal and external communications, establishing roadmaps and benchmarks, requirements gathering, development, implementation, testing and training plans, and ensuring the successful transition to the functional owners

Qualifications/Requirements    

This position is open to internal and external candidates.

• Bachelor’s degree and minimum 7 years experience in manufacturing, engineering, lean/six sigma, QARA, supply chain and/or IT; OR high school diploma/GED plus minimum 11 years working experience in manufacturing, engineering, lean.six sigma, QARA, supply chain and/or IT in a medical device environment)
• Demonstrated program/project management experience in a global environment, including project initiation, scoping, cost benefits, resourcing, scheduling, budgeting, requirements gathering, risk management, execution and communication
• Process improvement experience, knowledge of continuous improvement methodologies & in-depth understanding of related processes
• Excellent written and verbal communication skills in English
• Demonstrated effective interpersonal, teamwork, networking skills, collaboration, negotiation & conflict resolution skills; Ability to interface and influence at all levels in the organization
• Analytic, creative and business focused problem solver
• Change agent with energy, passion & enthusiasm to drive change
• Strong organizational skills
• Prior experience using word processing, spreadsheet, and presentation software
* You must be willing to take a drug test.
* You must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background.
* You must be legally authorized to work in the United States without work sponsorship at the time of hire.
* You must submit your resume through gecareers.com or a job board to be considered for a specific job opening (internal candidates should apply through COS).
* You must be willing to work out of a GE office in Waukesha, WI.

Additional Eligibility Qualifications    

For U.S. employment opportunities, GE hires U.S. citizens, permanent residents, asylees, refugees, and temporary residents. Temporary residence does not include those with non-immigrant work authorization (F, J, H or L visas), such as students in practical training status. Exceptions to these requirements will be determined based on shortage of qualified candidates with a particular skill. GE will require proof of work authorization. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.

Desired Characteristics  

 • Demonstrated experience with regulations in the medical device and/or pharmaceutical industries
• Demonstrated knowledge of Quality Management System tools
• Demonstrated knowledge of the GEHC IT infrastructure and virtual server concepts
• Exposure to the GEHC computer systems validation (CSV) work instruction and GEHC design controls
• LEAN experience
• Demonstrated ability to excel in a global matrix organization
• Ability to make decisions under pressure and take ownership for assigned projects and programs
• Ability to multi-task & handle tasks with competing priorities effectively