Senior Manager- IT Quality

Senior Manager - IT Quality

Responsibilities

• Team Leadership:

  Supervise, mentor, and oversee a team of quality professionals, managing day-to-day

  GxP

  activities and fostering a collaborative environment.

• Validation & Compliance:

  Guide the team in performing periodic reviews and audit trail assessments. You will manage change controls, and review and approve validation deliverables such as

  Validation Plans

  and

  Validation Summary Reports

  , ensuring they adhere to procedures.

• Quality Management:

  Serve as a Quality Contact for reviewing and approving failure investigations and

  CAPAs

  . You will also act as a Business Owner for Quality Assurance systems like

  SAP QM, Veeva, and Kneat

  .

• Supplier Management:

  Manage supplier relationships for computerized systems, including vendor selection, qualification, and contract management.

• Regulatory Support:

  Participate in and support regulatory inspections as needed.

• Process Improvement:

  Apply strong analytical skills to evaluate complex situations and use qualitative and quantitative data to drive continuous improvement in IT quality and performance.

Qualifications

• A Master's degree with a minimum of experience in Software and Systems Quality assurance, or a Bachelor's degree with more extensive experience. Leadership experience in this area is required.
• A strong understanding and ability to apply

  GxP requirements

  in Information systems.
• A strong understanding of regulations such as

  21 CFR Part 11, EU Annex 11,

  and

  GAMP standards

  .
• Experience with tools and systems like

  HP ALM, Jira, Confluence, and TrackWise

  .
• Experience in training others and developing training curriculum is a plus.

Competencies

• Leadership:

  Proven leadership skills with a passion for mentoring and developing talent.

• Problem-Solving:

  The ability to evaluate and interpret complex situations, and independently develop solutions that are thorough and practical.

• Strategic Thinking:

  Strong understanding of risk assessment and the ability to apply risk-based decision-making to all processes.

• Communication:

  Excellent project management, collaboration, and communication skills for working with cross-functional and global stakeholders.