Manager, IT Computer Systems Validation

2 weeks ago


Sunnyvale, California, United States Intuitive Surgical Full time
Job Description

Primary Function of Position:

The Sr. Manager of IT CSA drives quality transformation and system validation programs using risk-based approach. Expertise in managing IT GxP systems and leadership in GMP validation for Pharma/biotechnology/medical devices. This critical role ensures GMP compliance and works with Business/Owners and Quality teams to transition from CSV to CSA framework.

Roles & Responsibilities:

  • Develop strategies for continuous improvement aligned with Intuitive Surgical standards, customer needs, and regulations. Carry out hands-on execution of these programs effectively.
  • Provide oversight for Validation/Quality process. - Manage and ensure effectiveness of GxP-related systems. - Support Intuitive Surgical improvement projects.
  • Manage a hybrid team of onshore / offshore resources, which include high performing Validation Engineers and contractors.
  • Compile and assess quality metrics to enable a data-driven framework and build the strategy for improving quality initiative.
  • Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Annex 11, GAMP5.
  • Solid knowledge of Medical Device standards such as 21 CFR 820, ISO 13485, ISO 14971.
  • Define opportunities for their team and support resource prioritization.
  • Support team to produce high quality, consistent documents that meet Intuitive Surgical's requirements.
  • Oversee the overall readiness of the CSV and Data Integrity programs to ensure programs are compliant.
  • Assess systems for data integrity and compliance with regulatory expectations including assessment of third-party IT service suppliers and applications.
  • Effectively identify and resolve complex system for compliance issues and appropriately communicates gating items to management and stakeholders.
  • Review/assess proposed validated system changes via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status.
  • Participate and support the external audit programs related to GXP computerized systems.
  • Evaluate and recommend QA process changes by keeping abreast of the requirements for compliance in own area of work.
  • Authoring and/or revising SOPs, providing guidance on revising validation documents and protocols.
  • Training and support of team, as well as training and support of larger team on compliance and quality concepts.
  • Advocating for product and process quality. Helps teams meet compliance standards. Does so with practicality and patience.
  • Drive continuous education & awareness of company policies.
  • Ability to motivate, manage performance, and mentor direct reports effectively.


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