Senior Manager - IT Quality

Responsibilities

• Strong project management skills with experience supervising quality professionals working with cross functional and global stakeholders across multiple time zones.
• Develop, Mentor, and oversee staff and day-to-day GxP activities.
• Assess and guide the team in performing Periodic Review of Systems and Audit Trail Reviews.
• Manage change controls, validation and review and approval of validation deliverables per procedure (e.g. Validation Plan, Test Strategy, Validation Summary Report, etc.).
• Supplier Management activities for Computerized Systems and other validation disciplines / processes (e.g. Equipment, Analytical, etc.)
• Support, review and approval of failure investigations & CAPA as a Quality Contact pertaining to Computer Systems.
• Business Owner activities for systems owned by Quality Assurance (e.g. SAP QM, Veeva, Kneat).
• Participation and support of regulatory inspections as needed.
• Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems.

The following are some examples of tasks for the position

Basic Qualification

Preferred skills

Skills Required

Qa, Qms, Jira