Sadia Niazi linkedin.com/in/sadia-niazi-*****bb

adgb0z@r.postjobfree.com 631-***-****

Manager Quality Validation

Project Management Product Management Continuous Improvement Process Improvement Change Management

Extensive experience in Quality Management, Compliance, and Process Improvement. Strategic Leader with a record of accomplishment in driving continuous improvement, quality assurance, and compliance in complex IT operations. Well versed in project management, including planning, testing, and releasing quality products. Implemented and supported compliance with Quality, IT and SDLC processes, industry best practices, and federal regulations in both the pharmaceutical and aviation industry.

Quality Assurance Quality Control Quality Management Risk Management Validation Audits

Six-Sigma Waterfall Agile SDLC/PDLC Quality Center ServiceNow SharePoint

SAP FDA FAA SOPs ITIL CFRs 21 CFR Part 11 FAR 117 ISO 9001 (2008 2015) CAPA RCA

Experience

Manager Quality Control & Compliance -- JetBlue Airways (Jan 2017 - Present)

Managed compliance of IT and Project Delivery policies, procedures, and regulatory specifications for new code introduced into the production landscape. Ensured work practices aligned with all audit, security, and regulatory requirements and company policies—conducted peer reviews for all IT Operations and Corporate projects deployed to production to ensure compliance.

Partnered with stakeholders to deliver the IT strategy and an annual plan to support the business functions, including product roadmaps. Collaborated with other IT Managers and peers to ensure alignment across projects and programs to drive standards and efficiencies.

Introduced and maintained proper quality control checks to ensure a stable production environment. POC to Enterprise Release Management for IT Operations and Corporate Products.

oDeveloped, deployed, and managed a controlled production release process.

oFacilitated change control management of production and non-production environments.

oDetermined KPIs to measure and identify trends for reporting to senior leadership.

Identified and implemented areas of improvement in the project, product, and operational processes or practices.

Process Improvement -- Implemented policies, procedures, and added quality gates to increase consistency, quality, and support for products and product rollouts. Created a Deliverables Checklist for Waterfall and Agile projects and introduced a Peer Review process that drove a 40% reduction in post-implementation incidents and a significant reduction in time spent on incident resolution calls by the project team and leadership.

Project Management Tools – The PMO wanted to increase PM engagement on the Project Management tool, Workfront. Engagement increased from 50% to 85% by optimization of the tool, including eliminating redundancies in checklists and processes. Worked with the vendor to address PM concerns, provided additional training on functionality, and added customization to the tool to streamline and make the tool more user friendly.

Problem Management Tools -- Worked with the Service Management team to build a dashboard to provide IT Ops and Corp Leadership and Product Owners a consolidated view of defect, incident, and problem management tickets from the Service Management tool and SharePoint easier to identify. Product owners resolved 90% of open tickets on or before the ticket reached SLA max, and recurring tickets have documented action plans/associated notes.

IT Product Manager (Jan 2016 - Jan 2017)

Managed a portfolio of products within the IT Operations Product Team. Oversaw multiple cross-functional teams to deliver high-quality products aligned with requirements, strategic initiatives, and increasing efficiencies. Served as the first point of escalation for project and product-related risks, issues across all environments.

Led all aspects of product development, including project team definition, project planning, documentation, contract, and budget management; oversee project execution, tracking, reporting, rollout, interface with training and support groups, and program communication.

oServed as a Subject Matter Expert and coordinated the development of the product roadmap with Business and Matrix Partners– planned, created, and maintain an 18-month roadmap that determined milestones, upgrades, and implementation timelines.

oResearched and recommended emerging technologies integration into core business functions

Participated in the Acceptance Testing and Quality control to ensure the end-product meets the business vision.

oIdentified Product Quality metrics that met or exceeded objectives, benchmark, and initiate continuous improvement best practices to ensure minimum business functions disruption.

Leadership – initiated a process to build a team consisting of matrix partners to manage four separate Product Portfolio areas (Fuel, Corporate Security, Corporate (SAP and non-SAP), Centralized Publications. Met with the team biweekly to build overall product strategy, project prioritization, and identifying concerns and risk mitigation. Created and maintained a rolling 12-18 month product roadmap for each of the portfolio areas.

QA – supported portfolio owners as a QA SME and liaison to IT to address any defects, hotfixes, patches, and future rollouts and manage their product expectations. Introduced Agile or hybrid testing practices and increased product quality and oversight on project deployments aided by enforcement of established policies and procedures. The appropriate testing strategy identified stoppers earlier in the process and shortens time to production with an overall improvement in quality.

Quality Management Specialist -- JetBlue Airways (Jan 2013 - Jan 2016)

Developed continuous improvement strategies to drive quality standards in all IT solutions and assured compliance with the IT Service Delivery Framework, including Program, Project, and Software Development Life Cycle processes. Drove core functional excellence in implementing industry best practices and six sigma or lean initiatives.

Continuous Improvement

Developed the IT Service Management Framework according to ITIL standards and industry best practices.

Introduced a culture of quality and process improvement by supporting team members across the IT organization through continuous improvement concepts, projects, and methodologies.

Identified areas of improvement through root cause or statistical analysis, metric collection, data analysis and interpretation, and process flow review.

Introduced standardized SDLC methods and tools to establish project management and delivery best practices throughout the entire organization. Created, reviewed, and maintained policy and process documentation (a list of standardized templates with document control).

oEstablished document control procedures and trained 200+ crewmembers and business partners on SDLC and project management best practices.

Quality

Defined and managed quality entrance and exit gates.

Conducted quality assessments to ensure IT initiatives comply with IT quality criteria.

Worked with the project teams on understanding the critical link between low quality and risk.

Quality Management Specialist -- JetBlue Airways (continued)

Process Improvement

Applied Lean Six Sigma methods to identify and improve several IT-supported areas such as Crew Services and Inflight operations.

Automated Testing -- Reduced overall testing time for Crew Services by automating scripts, creating or revising a suite of regression test scripts, and removing unnecessary sign-offs.

Workflow Improvements -- reduced redundancies in capturing performance-related metrics for Inflight operations. Created a better workflow in SharePoint for information gathering, made recommendations to ensure the secure storage and access of information securely stored and only accessible based on Security and HR/People team policies and any compliance regulations.

Quality Assurance Analyst -- Pall Corporation (Jan 2011 - Jan 2013)

Ensured FDA and GxP Compliance for SAP implementation globally. Reviewed SAP BPPs; created and reviewed SOPs for SAP. Reviewed Change Requests and provided QA approval for the following SAP modules: MM/WM, FI/CO, SD, PP, and HCM.

Validated computer systems' regulatory compliance by performing risk assessments, gap analysis, 21 CFR Part 11 assessments, audits.

Prepared and approved validation documentation for computerized systems (validation plans, requirement documents, test scripts, traceability matrices, and final reports).

oValidated the Change Management system, LANDesk.

Developed test scripts (with BPO/IT) and provide oversight to the execution of test scripts.

Worked with Business Process Owners (BPO) to collect and develop User and Functional Requirements.

Quality Management System, Validation of Pilgrim Upgrade -- Several sites and workgroups utilized the QMS tool differently. Selected a suite of regression scripts to account for the differences in software use and ensured that several systems maintained performance and reliability after installing software upgrades or new functionality.

Additional Experience

Sr. Validation Analyst -- ICON Central Laboratories (Jan 2008 - Jan 2011)

Evaluated and validated computer systems for regulatory compliance. Identified, reporting, and tracking issues, bugs/defects using Test Track Pro, and interacting with developers to resolve open issues, re-testing for bugs.

Audit participation in internal/third party and FDA audits, CAPA (Corrective and Preventative Actions)

Validation Consultant -- Forest Laboratories (Jan 2006 - Jan 2008)

Validation of system functionality according to business requirements. Completed documentation of mappings and standardizations for Informatica. Executed weekly Change Control dry run and validated testing, including writing, reviewing, and executing test scripts/test cases for SAP CRM, FRXSell, BW, ECC, Basis, Rep Enhancements.

Validation Specialist -- Luitpold Pharmaceuticals (Jan 2003 - Jan 2006)

Creation, execution and review of IQ, OQ, PQ documents and executed 21 CFR Part 11 assessments, remediation plans.

Education and Professional Development

Bachelor of Science, Computer Science Technology and Business Management, SUNY Farmingdale, NY

Six Sigma Green Belt

ISTQB (International Software Tester)

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