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Job Description: Project Consultant Business Analyst - PQC Simplification Project
This position will be located in New Brunswick, New Jersey, reporting into Quality Director, Product Complaint Management.
1. Assess as-is processes, technology landscape and data to identify improvement opportunities
2. Lead the business process simplification for Global Product Quality Complaints
• Drive key business process requirements gathering from Subject Matter Experts (SMEs) across BMS sites and local markets
• Manage project needs and engage support from SMEs globally
• Conduct working sessions with SME for requirement definition
• Establish project milestones and work towards targeted deliverables for each work stream
• Manage the improvement activities through established project management tools
• Document detailed process flows
3. Conduct functional fit-gap analysis for redesigned processes and document to-be requirements
4. Develop key deliverables of User Requirement Spec (URS), Functional Spec (FRS), validation plans, risk assessment and IQ/OQ/UAT test scripts
5. Prepare training material, system guides and Standard Operating Procedures (SOP) for the to-be system
6. Provide project updates to project stakeholders, sponsor, and management as necessary
7. Escalate issues to management in a timely manner with proposals to resolve
8. Execute validation and testing activities to qualify PQC systems in GxP environments
9. Partner with identified Change Champions for site readiness activities
10. Perform other duties within the scope of the project as assigned.
This position requires minimum of 5-years of relevant experience. Experience in consulting as a business process transformation/Solutions Architect/ Validation Lead in enterprise transformation projects with focus on Quality Management Systems within a regulated health care industry. Have good understanding of GxP standards, 21 CFR Part 11, System Development Lifecycle (SDLC) in hybrid agile and waterfall methodologies.
Minimum of a Bachelor's Degree in Engineering or life sciences is required. Experience in implementing quality risk management strategies within business processes is required. Project Management and Six Sigma certification required.
• Analyzing data and identifying issues/areas for improvement is essential.
• Ability to communicate effectively on a professional level
• This individual should have creative problem solving and critical thinking skills.
• Experience in "continuous process improvement " is required
• Work with minimal supervision, engage appropriate departments, obtaining necessary information to make informed decisions and recommend solutions
• Demonstrated understanding and application of CGMPs, Quality Systems, relevant laws, guidance, and directives, and current industry practices.
• Attention to detail, ability to work and coordinate activities with multiple functional groups and with the sense of urgency
• Ability to prioritize, plan, and schedule.
• Strong oral and written communication skills, MS Office experience is required,
• Project management experience required.
Additional Job Requirements:
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