• Helped automate, streamline, and implement GMA processes with global Cross-functional (R&D + GMA) Stakeholders and End-Users.
• Initiated Quality Council for GMA.
• Implemented ArisGlobal's LifeSphere Product Suite to help streamline and enhance global business processes for Global Pharmacovigilance, Global Intake with matrixed oversight of IT, Business (GMA & R&D) and Vendor resources.
• Responsible for Operational Budget, IT, Vendor Management, Configuration, Change & Incident Management.
• Managing all Quality, Program Mgmt., IT, CSV, and Compliance (including Process Mgmt., Periodic Review and CAPA Mgmt.) related activities internally and externally for GMA.
• Co-leading change management and training activities globally for systems being implemented and processes being digitized in collaboration with Business and other functions.
• Led audits for GMA IT inspections including training for inspection/audit readiness and mock inspections.

• Assessed QMS for process improvements and building quality in for GxP & Non-GxP programs in R&D functions.
• Evaluated and implemented R&D systems based on Agile/Waterfall & Lean principles.
• Assessed IT & QMS for process improvements and building quality in for best-in-class IT solutions (GxP and Non GxP).
• Implemented Voice of Customer based innovative initiatives to help enhance Product Quality and Digitize business processes.
• Helped Pharmaceutical and Biotech companies establish Quality / Auditing, PV (Safety), and Medical Information departments to prepare for product launch and Health Authority Audits.
• Helped co-lead Inspection readiness trainings and mock inspections.

• Led global QA organization and provided QA strategic guidance in key Quality matters for all Technology related System Assurance activities. Faruqi
● Bridgewater, NJ 08807 908.720.2480 www.linkedin.com/in/alifaruqi/ ali.faruqi17@gmail.com
● • Managed a high-performance team of 10 global FTEs internally in addition to ~600 global vendor resources with budget of ~$68M (across J&J Pharma, Consumer, Supply Chain, Medical Devices and Corporate business units) –
responsibility for Capex and Opex of department.
• Architected, developed, and deployed industry leading Global Enterprise Quality Engineering program for both regulated (GxP, SOX, Privacy, Security) and non-regulated environments, driving $50M+ in efficiency gains as part of QMS improvement.
• Executive Sponsor of innovative concepts for development, implementation and launch of global, enterprise-wide initiatives.
• Major accomplishments:
• Develop and oversaw Implementation of QA Strategy for enterprise-wide processes glo

• Developed MDM Strategy + Roadmap for key R&D business units, including software & vendor evaluation,strategy & implementation.
• Led client engagements that redesigned the IT & Quality processes with both Waterfall and Agile frameworks incorporated for both GxP and Non-GxP projects, in addition to Incident Management and IT Support.
• Initiated and shepherded the design and implementation of large scale, enterprise R&D IT projects; maintained integrated IT program plans; and consistently delivered on projects in a timely and cost-effective manner with high business satisfaction.
• Interviewed all levels within Business and IT (Pre-Clinical, R&D, Commercial, Supply Chain and Finance) in addition to QA (Compliance, Validation, Quality and Audit) to understand key pain points and KPIs needed to measure improvements to improve IT Services, including Support.
• Led Inspection readiness trainings and mock inspections.

• Oversaw Business QA / Validation and Testing efforts for multi-million-dollar program, ensuring adherence to Novo Nordisk standards for compliance against Track and Trace regulatory requirements in addition to Sunshine act. Faruqi
● Bridgewater, NJ 08807 908.720.2480 www.linkedin.com/in/alifaruqi/ ali.faruqi17@gmail.com
● • Quality & Risk Manager across US $130M Global SAP-ERP implementation program, overseeing phase closures, and confirming alignment with quality methodologies through all aspects of program including alignment with GxP (GCP, GMP) and SOX requirements.
• Executed and Supported audits as part of QMS, IT and Risk assessments.
• Developed and published POVs and whitepapers for Risk Advisory Practice, predicting impact of cloud technology on SDLC and VLC in regulated environments and how Business Processes will transform leading to early adoption of client's adopting cloud.

• Program Management lead for various mission critical client IT initiatives.
• Led assessment and implementation of Global Project Delivery Office (PDO) for Enterprise IT (Infrastructure, Security, and Architecture) organization, managing capacity and throughput of ~650 personnel.
• Implemented Global Documentum Shared Services initiative for 25 application migrations, and
● 100 terabytes of data, leading Qualification Team for all matters related to Quality Assurance, Validation and Testing, maximizing existing QMS.
• Supported Audits and CAPA programs for Clinical systems on behalf of IT.
• Implemented GxP Audit and CAPA program for an emerging pharmaceutical company within Supply Chain division.

• Validation Project Manager for ~$37MM Pharmacovigilance DB in addition to CTMS, Regulatory Affairs and Labeling systems.
• Assisted with Enterprise-wise QMS standard upgrade.
• Conducted International and local Quality Audits of various CROs, Specialty Labs sites and CMOs.
• Actively (in-room with auditors and part of audit prep activities) coordinated/participated in Internal & External Health Authority Audits (EMEA/MHRA, FDA) supporting PV, Clinical & IT.
• Led QA & validation efforts of computer system related projects to maintain compliant with various Health Authorities (EMEA, FDA, JPAC, and ICH) regulations.
• Actively took part in monthly Quality Metrics gathering for Pharmacovigilance business unit, updated management with analysis.
• Supervised and mentored Senior & Junior level Project Managers, Analysts, and contractors within various business units.
• Quality Lead for Clinical Trials and Lab areas in addition to equipment qualifications in manufacturing.

• IT PM, Validation and Quality Lead Clinical Operations on-site at Schering-Plough.
• IT PM and Project Lead for drug launch and FDA submission for emerging biotech.
• PM and Lead assessor for Part 11 Assessment and Remediations including SOP development.