AsSenior Manager Quality Assurancein theIT Qualityorganization, you're in a leadership position with responsibilities to supervise and mentor staff. Each staff member will participate/support different phases of the Information Systems Lifecycle. As a leader you will focus your efforts on the following workflows in a GxP environment:
Focus Areas
- Computer System Validation (CSV) with a strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards.
- Strong understanding of periodic reviews and audit trail assessments for computer system validations, ensuring compliance, system integrity, and risk identification.
- Manages supplier relationships for software applications, including vendor selection and qualification, contract management, and ensuring timely and quality software delivery.
- Oversees the Quality Management System (QMS) for computerized systems, ensuring compliance, documentation, and continuous process improvement.
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
- Strong understanding of Risks Assessment and how to apply risk-based decision making to all processes related to IT systems.
- Determine and establish requirements for system/equipment or processes.
- Act as a reviewer and approver for SOPs, validation deliverables and /or QMS related records (Deviation/CAPA).
- Review and Approve System Life Cycle Documents (i.e. Validation deliverables).
- Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
- Leverages qualitative insights and quantitative research, analyzes trending data, and utilizes forecasting models and advanced analytical tools to drive continuous improvement in IT quality and performance.
- Anticipates and prevents potential problems.
- Independently develop solutions that are thorough, practical and consistent with functional objectives.
- Provides management review updates on quality metrics, analyzing data and recommending improvements to enhance quality standards.
- Bring topics and critical decisions to managements attention and initiate and enforce necessary improvements and corrections to established systems and processes compliance.
Basic Qualification
- Masters degree with a minimum of 10 years experience in Software and Systems Quality assurance (Experience of minimum 5 years in leading teams in this area of expertise and foster an environment of strong collaboration) OR
- Bachelors degree with a minimum of 14 years experience in Software and Systems Quality assurance (Experience of minimum 5 years in leading teams in this area of expertise and foster an environment of strong collaboration).
- Strong understanding and ability to apply GxP requirements in Information systems.
- Possesses a strong understanding of industry standards and business principles.
- Contributes to work group/team by ensuring quality of tasks/ services provided by self and others.
- Candidate may need to work hours outside the standard workday or work in different time zones to support business needs.
Preferred skills
- Demonstrated experience (3-5 years) training others in activities outline above.
- Establish/Improve and actively participate in training curriculum and delivery of this material.
