Joseph A.

About Joseph A.

Experienced Life sciences, Healthcare technology leader with over 25 years of progressive experience managing complex technology initiatives in highly regulated pharmaceutical, biotechnology, and healthcare environments. Proven ability to lead cross-functional teams, drive digital transformation, and ensure compliance with global regulatory standards. Recognized for exceptional organizational, technical, and communication skills, coupled with a strong commitment to quality, execution, and customer service.A results-driven and self-motivated professional with over 20 years of specialized experience in IT and Project Management within the Pharma & Biotech industry, including infrastructure, applications, automation systems, and validated environments.Industry Expertise: Extensive experience in Pharmaceutical, Biotechnology, and Healthcare IT, including Applications Development, Implementation, Data Center Operations, and Computer System Validation (CSV).Leadership & Program Management: Skilled in leading diverse, cross-functional teams to deliver complex projects and meet strategic objectives in fast-paced, high-pressure environments.IT & Business Systems Expertise:Quality Systems: Veeva QMS, DMS, LMS, Trackwise, Blue Mountain Calibration/PMClinical Systems: Veeva EDC/CDMS, CTMS, eTMFRegulatory Systems: RIM, PublishingCommercial Systems: Veeva Align, Events, CRM (Veeva/Salesforce), MedComms, PromoMats, Veeva Nitro, Veeva Network, OpenDataEnterprise Systems: ERP (NetSuite, PBCS, MS Dynamics), COUPA (Purchase-to-Pay), Salesforce Health CloudManufacturing & Automation: Unicorn, MFCS, Water Empower, Honeywell EMS/BMSSerialization & Traceability: TracelinkCompliance & Governance: Deep knowledge of GxP (GMP, GCP, GLP), GAMP 5, 21 CFR Part 11, GDPR, DSCSA, ICH, and SOX regulations.Quality Documentation: Development and implementation of SOPs, GxP/SOX Policies, and Validation Master Plans.Audit & Inspection Support: Extensive experience managing and participating in FDA, EMA, Health Canada, and NMPA inspections, including mock PAI audits.Strategic Impact: Proven success in supporting commercial drug launch activities and collaborating with Commercial Operations to ensure readiness and compliance.

Experience

1. Head of Business Systems, Data and IT Compliance

   Rocket Pharmaceuticals

   Mar 2024 — Present · Cranbury, NJ, US

   This is a business technical leader role and will oversees the applications, development, maintenance, and improvement of delivery operations for a portfolio of business applications to deliver IT serviceimprovement to the business. This role will be responsible for ensuring the operational efficiency and effectiveness for all Service Operations and Applications Maintenance and Cloud SaaS applications support activities and architecture strategies. Will maintain responsibility for the overall operational health for all Applications company wide and policies in alignment with all compliance and regulatory demands for a biopharma company (i.e. SOX, 21 CFR Part11, HIPAA, GxP, GAMP-V, GDPR etc.).• Business focused technology leadership• Building trust to drive business efficiencies• Agile, scalable and compliant way to deploy the systems• Follow the current guidelines/principles and look for efficiency - not to disrupt the business operations – i.e, Operational Excellence• Communication, training, documentation and efficient support model

Education

• NJIT

  MBA in Information Technology, Information Technology

  2001 — 2003

• The University of Texas at Austin

  Post Graduate Program in Artificial Intelligence and Machine Learning: Business Applications

• Bharathiar University

  Bachelor of Engineering in Computer Science and Engineering, Engineering in Computer Science

  1991 — 1995

• The University of Texas at Austin

  Post Graduate Program in Artificial Intelligence and Machine Learning: Business Applications, Artificial Intelligence (AI) and Machine Learning (ML): Business Applications