What are the responsibilities and job description for the CSV Data Integrity Lead IT-QA position at Montek System?
Job Details
Data Integrity Lead - Quality Information Systems (IT-QA)
GENERAL POSITION SUMMARY:
Quality oversight of Data Integrity and Technology for GxP lifecycle activities and practices for Vertex Portfolio Programs. Additionally, acts as a Subject Matter Expert for electronic Data Integrity topics.
KEY RESPONSIBILITIES:
The responsibilities of this position may include, but are not limited to, the following:
Facilitate holistic data integrity reviews by partnering with QA and stakeholders to conduct end to end business processes assessments.
Prioritize gaps and risks and provide oversight to needed remediation activities.
Serving as a Strategic Quality Lead (providing project management, leadership, and participation) for DTE computerized system life cycle (SLC) activities for Vertex GxP systems.
Managing and Facilitating Data Mapping initiatives for programs level processes.
Providing Business Analyst skills and resources to projects across QA to facilitate requirements gathering, development of process/ data flow maps, and data integrity assessments.
Authoring, reviewing, and approving work process documents (SOPs and Work Instructions).
Generating and maintaining metrics for Quality Leadership Teams.
Identifying and implementing continuous improvement opportunities.
Leading oversight of electronic data integrity compliance guidance for Vertex GxP systems.
Assessing emerging needs in the industry to identify technology/ skills gaps within the team.
Coordinating with project stakeholders, GxP QA areas, and business representatives to ensure QISM is involved, informed, and accountable for Program activities and initiatives within the QISM scope.
