Senior IT Business Analyst - (Gmp Manufacturing & Quality Operations)

Planet Pharma Morris Plains , NJ 07950

Posted 3 months ago

GENERAL SUMMARY (FUNDAMENTAL PURPOSE OF THE POSITION)

The Senior IT Business Analyst is responsible for business analysis within the GMP Manufacturing and Quality business technology area, supporting global Supply Chain, Manufacturing, Quality, and other Operations support functions. The position is responsible for overseeing activities for gathering, analyzing and prioritizing functional and non-functional requirements to facilitate the development of systems or technical solutions for complex business issues. This includes development of comprehensive domain business process models used to guide continuous improvement initiatives and overall understanding of the business processes key to Operations. The Senior Business Analyst works closely with key business stakeholders, SMEs, IT peers, validation and other team members to identify and document business requirements needed to identify possible solutions for data, processes, interfaces, controls, systems, outputs, etc.

The Senior IT Business Analyst Operations and Quality will work in partnership with other domain business analysts in the development of best practices, standardized templates and business analyst methodologies to be practiced across the organization.

ESSENTIAL JOB FUNCTIONS* (PRIMARY RESPONSIBILITIES)

  • Participate as a Business Requirements Subject Matter Expert to support the development of business requirements documentation, technical designs, test strategy and plans, etc.

  • In partnership with the domain IT lead, drive a portfolio of information system initiatives, programs, projects and services to optimize business process solutions within the domain.

  • Build effective working relationships and collaborate with other domain and enterprise resources to ensure customer needs are being met.

CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES)

  • Domain Knowledge:Understands the pharmaceutical/biotech industry and how it operates; Demonstrates strong domain knowledge and how technology solutions can improve or enhance existing processes and overall business results; well versed in global GxP and Computer System Validation practices; solid understanding of the regulatory environment and industry standards (i.e. 21 CFR Part 11, Annex 11, GAMP 5, etc.).

  • Process Design / Re-Engineering: Analyzing design of business workflows, recommending changes to business processes under the framework of the domain goals; good at figuring out and documenting the processes necessary to accomplish domain business objectives; can simplify complex processes; understands how to separate and combine tasks into efficient processes.

  • Test Strategy Definition: Creating a comprehensive testing strategy, including test plans and test data plans across all phases of the SDLC.

  • Dealing with Ambiguity: Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; remains calm, effective and practical when dealing with ambiguity; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty

  • Communication: Excellent written and oral communication skills; able to engage with multiple levels of the organization

EDUCATION/ EXPERIENCE (MUST INCLUDE MINIMUM REQUIREMENTS NECESSARY TO PERFORM ESSENTIAL JOB FUNCTIONS; ADDITIONAL PREFERENCES OPTIONAL)

  • Bachelors degree in Computer Science, Business or closely related field from accredited college or university, or equivalent experience

  • Minimum of 5 years relevant work experience as a business analyst, including hands-on experience with domain systems (i.e., ERP, MRP, QMS, LIMS, etc.) in support of global business operations

  • Minimum of 5 years relevant work experience in global pharmaceutical/biotech organizations

  • Strong knowledge of Supply Chain, Manufacturing, and Quality operations and processes

  • Experience in and awareness of emerging business process automation trends and tools

  • Detailed knowledge of current Good Manufacturing Practices, Computer System Validation requirements (i.e. 21 CFR Part 11, Annex 11) and GAMP 5

  • Certification / experience in Operational Excellence / Six Sigma highly desired

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VIEW JOBS 10/14/2020 12:00:00 AM 2021-01-12T00:00 Overview The Senior IT Business Analyst is responsible for business analysis within the GMP Manufacturing and Quality business technology area, supporting global Supply Chain, Manufacturing, Quality, and other Operations support functions. The position is responsible for overseeing activities for gathering, analyzing and prioritizing functional and non-functional requirements to facilitate the development of systems or technical solutions for complex business issues. This includes development of comprehensive domain business process models used to guide continuous improvement initiatives and overall understanding of the business processes key to Operations. The Senior Business Analyst works closely with key business stakeholders, SME's, IT peers, validation and other team members to identify and document business requirements needed to identify possible solutions for data, processes, interfaces, controls, systems, outputs, etc. The Senior IT Business Analyst Operations and Quality will work in partnership with other domain business analysts in the development of best practices, standardized templates and business analyst methodologies to be practiced across the organization. Responsibilities * Participate as a Business Requirements Subject Matter Expert to support the development of business requirements documentation, technical designs, test strategy and plans, etc. * In partnership with the domain IT lead, drive a portfolio of information system initiatives, programs, projects and services to optimize business process solutions within the domain. * Build effective working relationships and collaborate with other domain and enterprise resources to ensure customer needs are being met. Qualifications * Bachelors' degree in Computer Science, Business or closely related field from accredited college or university, or equivalent experience * Minimum of 5 years relevant work experience as a business analyst, including hands-on experience with domain systems (i.e., ERP, MRP, QMS, LIMS, etc.) in support of global business operations * Minimum of 5 years relevant work experience in global pharmaceutical/biotech organizations * Strong knowledge of Supply Chain, Manufacturing, and Quality operations and processes * Experience in and awareness of emerging business process automation trends and tools * Detailed knowledge of current Good Manufacturing Practices, Computer System Validation requirements (i.e. 21 CFR Part 11, Annex 11) and GAMP 5 * Certification / experience in Operational Excellence / Six Sigma highly desired * Domain Knowledge: Understands the pharmaceutical/biotech industry and how it operates; Demonstrates strong domain knowledge and how technology solutions can improve or enhance existing processes and overall business results; well versed in global GxP and Computer System Validation practices; solid understanding of the regulatory environment and industry standards (i.e. 21 CFR Part 11, Annex 11, GAMP 5, etc.). * Process Design / Re-Engineering: Analyzing design of business workflows, recommending changes to business processes under the framework of the domain goals; good at figuring out and documenting the processes necessary to accomplish domain business objectives; can simplify complex processes; understands how to separate and combine tasks into efficient processes. * Test Strategy Definition: Creating a comprehensive testing strategy, including test plans and test data plans across all phases of the SDLC. * Dealing with Ambiguity: Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; remains calm, effective and practical when dealing with ambiguity; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty * Communication: Excellent written and oral communication skills; able to engage with multiple levels of the organization #LI-RA1 Immunomedics, Inc. Morris Plains NJ

Senior IT Business Analyst - (Gmp Manufacturing & Quality Operations)

Planet Pharma