Lead IT Quality Assurance Manager

3 weeks ago


Raritan, New Jersey, United States Johnson and Johnson Full time

As a valued member of the Johnson & Johnson team, you'll have the opportunity to contribute to the company's mission of creating a healthier, more equitable world. The Lead, Computer System Validation will be responsible for ensuring the quality and integrity of our enterprise-wide systems, which is crucial to delivering innovative solutions to patients worldwide.

About the Job

This role requires a strong leader who can guide a team through the process of validating computer systems used across our organization. The ideal candidate will have a solid understanding of GAMP-5, 21 CFR-Part-11, and CSA, as well as experience with technology systems and process analysis tools. They will also be able to develop and implement a risk-based approach to CSV and manage timelines while overseeing contract resources.

Key Responsibilities
  • Execute GxP systems according to approved procedures and policies.
  • Lead Computer System Validation of ERP/WMS, R&D, and Commercial systems.
  • Facilitate and communicate key messages and presentations to various cross-functional groups.
  • Develop and implement a risk-based approach to CSV.
  • Approve SDLC validation documentation deliverables.
Requirements

To succeed in this role, you'll need:

  • A minimum of four to six years of related experience in a Quality, Validation, and/or IT function.
  • Progressive experience in the pharmaceutical/med device/biotech industry with direct experience in Healthcare Technology activities.
  • Experience in identifying areas of potential compliance risks and implementing strategies to reduce those risks.
  • Familiarity with procedures, work instructions, forms, and templates.
  • Familiarity with Change Control and NC/CAPA generation/approval.
Compensation and Benefits

We offer a competitive salary range of $91,000 to $147,200 per year, along with a comprehensive benefits package that includes medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Our employees also participate in a consolidated retirement plan (pension) and savings plan (401(k)). Additionally, you'll receive paid time off, including vacation, sick leave, holiday pay, and floating holidays.



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