QMS / Manufacturing Business Analyst

Category: Business Consulting, Strategy and Digital Transformation
City: Plymouth Meeting, Pennsylvania, United States
Position ID: J1219-0101
Employment Type: Full Time
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Position Description

POSITION DESCRIPTION

This individual will be working with various sites QMS (Quality Management System) and Manufacturing teams to support ISO9001 inspection readiness for Middle-Eastern countries. Client would like to engage the supplier for an SME lead that can perform a gap anlysis across sites against local and international regulations. Also, to provide solution planning and action planning for remediation. This is a remote position with some client site activity, as required.



FUTURE DUTIES AND RESPONSIBILITIES

• Perform Lead BA activities for gap analysis against local UAE regulations of quality documents and analytical documents for sites and consumer products involved

• Lead workshops and Meetings

• Interface with the Project Team to ensure continuity across business and UAE requirements.

• Engage in knowledge transfer as needed to insure continued project success

• Lead and support gap analysis activities

• Lead overall deliverables

• Perform audits, as needed

• Take direction from the PM & Stakeholders

• Must have the ability to define business needs and analyze. This includes but is not limited to scoping, requirements development, process development, communications, planning for individual efforts.

• Needs to understand the basics of developing scope and requirements to create documentation.

• Design solutions for remediation of gaps found.

• Must have very strong core consulting skills.

• Strong quality and inspection readiness experience

• Must work very well as part of team.Identify opportunities to improve utilization of supported system(s) and improve business performance by developing a strong understanding of the business, business processes and key performance drivers.

• Identify and document the needs of multiple stakeholders.

• Identifying the current- and future-state business processes.

• Helping the business stakeholders envision the future and how their work will need to change to support the future.

• Facilitating design sessions with the implementation team to define the solution.

• Foster partnership with customers, stakeholders, sponsors.

• Provides end-user guidance and training as needed.



REQUIRED QUALIFICATIONS TO BE SUCCESSFUL IN THIS ROLE

• A bachelor’s degree in the health or life sciences or comparable work experience.

• A minimum of 7 years’ experience in a Quality or Regulatory field.

• Experience in inspection readiness and interpreting regulations.

• Exceptional analytical and conceptual thinking skills.

• A history of leading and supporting successful projects.

• Excellent planning, organizational, and time management skills.

• The ability to influence stakeholders and work closely with them to determine acceptable future state solutions.

• Ability to understand the workflow and business processes related to the application being supported.

• Ability to effectively interface with technical and nontechnical staff at all organizational levels.

• Ability to provide outstanding customer service, be a good listener and work well with others.

• Ability to learn new content areas and new skills quickly.

• Excellent meeting planning and facilitation skills.

• Excellent problem solving and analytical skills.

• General knowledge of hardware and software technologies.

• Excellent documentation skills.

• Excellent written, verbal communication and negotiating skills, with customers, team and stakeholders

• Outstanding attention to detail

• Competency in Microsoft applications including Word, Excel, PowerPoint, MS Project, Visio.

• Self-motivated with the ability to effectively multitask in a fast-paced environment.



DESIRED QUALIFICATIONS/NON-ESSENTIAL SKILLS REQUIRED

Organized and good at project planning

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Skills

  • Quality Assurance/QA Strategy
  • Communication (Oral/Written)

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CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at US_Employment_Compliance@cgi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

We make it easy to translate military experience and skills! Click here to be directed to our site that is dedicated to veterans and transitioning service members.