Data Integrity Project Manager

Location: Austin, TX
Department: Azzur Austin, LLC

Job Description

We at Azzur Group are looking for an experienced Data Integrity Project Manager to join our Azzur Consulting: Austin team. The Data Integrity Project Manger will be responsible for the planning & delivery of projects from scoping of work, defining schedule, planning resources, and then executing the project and closing it out. The focus of this role will be on managing data integrity projects to their completion related to equipment, instruments, and IT systems.
 
 
MAJOR ACTIVITIES AND RESPONSIBILITIES:
  • Lead the planning and execution of projects.
  • Ensure that the scope of the project is organized by deliverables, proper schedules are created and maintained, and that resources are managed to ensure timely completion of project elements.
  • Organize, lead and facilitate cross-functional project teams.
  • Provide a standard agenda and meeting summaries (discussion points, decisions, action-risk log).
  • Implement a project team meeting cadence which enables appropriate internal discussions and engagement/communication.
  • Assign and track specific functional accountabilities.
  • Actively conduct risk management within and across programs
  • Track and report program performance
  • Track, report & pareto delays
  • Assist with Data Integrity strategies related to the specific systems in scope of the project

Mindset / Behaviors / Culture:
  • Ongoing prioritization, risk management & decision making, conflict resolution; integrates customer requirements, contract knowledge & input from functional experts to drive execution, decision making and team ownership/accountability.
  • Focused on productivity, efficiency, simplification, right first time in program delivery (meeting customer requirements, cost reduction, growing business).
  • Strong verbal, written & presentation communications (one-on-one, teams/group, internal & client); effectively engages, facilitates, influences & motivates business & technical audiences.
  • Business acumen – working knowledge of drug technologies including vaccines, cell and gene therapy as well as data integrity principles.
  • Customer focus – builds & maintains collaborative working relationships with clients and internal colleagues and stakeholders; solicits and responds to client and internal stakeholder feedback; respectful of others across functions & levels;
  • Actively engaged, action-oriented, resilient, passionately neutral in leading programs & teams
  • Recognizes & thanks individuals and teams for jobs well done.   

 
REQUIREMENTS:
  • BS in chemistry, biochemistry, engineering or microbiology
  • MBA preferred.
  • Certifications preferred
    • Project/Risk Management certification (PMI-PMP, PMI-RMP) plus demonstrated practical experience.
    • Lean Six Sigma certification & demonstration of business impact preferred.
  • 5+ years of demonstrated experience:
    • Managing 1-4 projects.
    • Customer Relationship Management.
    • cGMP & FDA regulations.
    • GAMP5 and 21CFR Part 11 regulations
    • Leading-coaching-developing-motivating large cross-functional teams to achieve targeted results.
    • Problem solving & conflict resolution.
    • Knowledge of basic financial accounting.
    • Building trust, respect, and collaboration across the organization.
  • SharePoint, SmartSheet, and MS Office capability
  • Strong verbal and written communication skills and comfortably and clearly articulate issues across the organization.


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