Business Architect

Business architecture, GxP, Data migration, GMP, Pharmaceutics, QMS, Quality management, Trackwise, Veeva, Audit
Full Time
Depends on Experience

Job Description

Basic Qualifications:

  • 10+ Years of Development experience in a regulated pharmaceutical industry; preferably in a large biopharmaceutical company
  • Up to 10+ Years of experience in working with Quality Management Systems and 2+ years as a Quality Management System Business Architect

 

Job Requirements and Responsibilities:

  • Use of expert knowledge of GMP/GXP protocols, Standard Operating Procedures to ensure compliance. 
  • Apply industry best practices to business processes in current and future implementation of QMS systems
  • QMS experience should include Quality Docs, Audits, CAPA, Change Control, Deviation Management, Complaints.
  • QMS experience should include working knowledge of Veeva Vault, Digital Trackwise, ETQ.
  • Hands on work experience with Regulatory and SDLC artefacts
  • Organize and facilitate group discussion with Business focus groups, site visits, workshops and periodic presentations on System Strategy and Status to Senior and Executive Leadership.
  • Participate in all areas of system implementation life cycles
    • Working with Business teams to develop the initial Business Case and seek buy-in from a broader set of Business, IT and Quality stakeholders
    • Working with IT team to develop designs, roadmap for system implementation including integration with Enterprise Systems
    • Work with Project Management to define testing, data migration, global deployment approach.

Working with Quality representatives to support qualification needs and ensuring compliance with regulatory requirements

Dice Id : hcl001APP
Position Id : 6653749
Originally Posted : 2 months ago
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