Experience

• 

  Cloudrise

  • Director, Professional Services

    • Apr 2024 - May 2024

    Cloudrise acquired Dayspring Technology.

• 

  Dayspring Technology, Inc.

  • United States
  • Business Consulting and Services
  • 1 - 100 Employee

  • Principal Consultant

    • Jan 2023 - Apr 2024

    Dayspring brings diverse, professional experience to business customers seeking regulatory guidance and data security governance. We provide consulting to fledgling or developed organizations in the following areas: Quality and Information Security Management Systems, ISO certifications, Cloud Security, Internal and External Audit programs, information asset protection, GDPR, CCPA/CPRA, 23 NYCRR 500, State Data Privacy, NIST Cybersecurity Framework, 21 CFR Parts 820 & 11, Annex 11, Computer Systems Validation (CSV, GAMP, cGMP/cGLP), HIPAA, PCI-DSS

  • Senior Consultant

    • May 2018 - Jan 2023

• 

  PMRS Inc.

  • United States
  • Pharmaceutical Manufacturing
  • 1 - 100 Employee

  • Director, Quality Management & Technology

    • 2015 - May 2018

    Key Responsibilities:-Develops, plans, implements and maintains Quality Management System to comply with all regulatory/client requirements to ensure uninterrupted production and conformance to specifications.-Builds and supports continuous system improvement and expansion of QMS to meet new and revised standards and guidance.-Develops new procedures and validation plans to support new products, equipment and policy initiatives in Manufacturing, Analytical and Quality departments.-Document and investigate issues using various techniques to determine route-cause, corrective action and develop preventative measures.-Ensures regulatory direction and compliance across multiple standards: 21 CFR Part 11, Part 210 and 211, ICH Q7, EudraLex Volume 4, FDA & MHRA Data Integrity Guidance, ISO 9001, ISO 14001, ISO 27001 -Leads successful regulatory and client inspections from the FDA, MHRA, ANVISA and ISO. Site readiness and gap analysis reporting for new compliance standards.-Provide technology vision and leadership for corporation, including budgetary and systems implementation decision making. -CMO client and business development. Work directly with clients on developmental products and procedures, through all clinical phases, registration, commercial validation and inspection. Development technical quality and manufacturing service agreements.-Performs Risk Management, Risk Mitigation and Risk Reduction using PDCA and FMEA-Internal and External Audits for compliance and supplier qualifications.

  • Information Technology & Security Manager

    • Apr 2006 - 2015

    -Network and Information Security Compliance-Develop and maintain ISMS, QMS and EHS for ISO 27001, 9001 and 14001 certifications-Risk Management Program Development-Adhere to FDA, MHRA and cGMP standards-Systems Validation and Application Development-Project and Network Management-Internal Audit Certified-Manufacturing Processes and Electronic Batch Records

• 

  MediMedia, Inc.

  • Help Desk Manager

    • 2005 - 2006

    -Product Support Manager -Developed security and access policies for patient information-Developed client and product support matrix-Quality Assurance testing for all product releases-Adhere to HIPAA and JCAHO standards-HL7 Interface Development and Support

• 

  Doylestown Hospital

  • Network Services Coordinator

    • 1997 - 2005

    -Managed Network, Desktop and Help Desk team-Developed Network and Desktop Security Standards