Senior Manager- IT Quality

Senior Manager Quality Assurance

Focus Areas:

• Computer System Validation (CSV)

  : You'll bring a strong understanding of regulations like

  21 CFR Part 11, EU Annex 11, and GAMP standards

  .

• Periodic Reviews and Audit Trail Assessments

  : Ensure compliance, system integrity, and risk identification for computer system validations.

• Supplier Relationships

  : Manage software application suppliers, including vendor selection, qualification, contract management, and ensuring timely, quality software delivery.

• Quality Management System (QMS)

  : Oversee the QMS for computerized systems, focusing on compliance, documentation, and continuous process improvement.

Responsibilities:

• Possess strong

  project management skills

  with experience supervising quality professionals who collaborate 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 (e.g., Validation Plan, Test Strategy, Validation Summary Report, etc.).
• Handle

  Supplier Management activities

  for Computerized Systems and other validation disciplines/processes (e.g., Equipment, Analytical, etc.).
• Support, review, and approve

  failure investigations & CAPA

  as a Quality Contact pertaining to Computer Systems.
• Perform

  Business Owner activities

  for systems owned by Quality Assurance (e.g., SAP QM, Veeva, Kneat).
• Participate in and support regulatory inspections as needed.
• Utilize tools and systems such as

  HP ALM, Jira, Confluence, TrackWise, and Documentation Management Systems

  .

Example Tasks for the Position:

• Possess a strong understanding of

  Risk 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.
• Leverage qualitative insights and quantitative research, analyze trending data, and utilize forecasting models and advanced analytical tools to drive continuous improvement in IT quality and performance.
• Anticipate and prevent potential problems.
• Independently develop solutions that are thorough, practical, and consistent with functional objectives.
• Provide management review updates on quality metrics, analyzing data and recommending improvements to enhance quality standards.
• Bring topics and critical decisions to management's attention and initiate and enforce necessary improvements and corrections to established systems and process compliance.

Basic Qualifications:

• Master's degree with a minimum of

  10 years of experience in Software and Systems Quality Assurance

  (including a minimum of 5 years experience in leading teams in this area and fostering strong collaboration)

  OR

• Bachelor's degree with a minimum of

  14 years of experience in Software and Systems Quality Assurance

  (including a minimum of 5 years experience in leading teams in this area and fostering strong collaboration).
• Strong understanding and ability to apply

  GxP requirements

  in Information Systems.
• Possess a strong understanding of industry standards and business principles.
• Contribute to work group/team by ensuring the quality of tasks/services provided by self and others.
• Ability to work hours outside the standard workday or in different time zones to support business needs.

Preferred Skills:

• Demonstrated experience (3-5 years) training others in the activities outlined above.
• Ability to establish/improve and actively participate in training curriculum and delivery of this material.