Lead Computer Systems Validation Latam

If you accept this position, it is anticipated that upon completion of the transaction, you will be an employee of a new entity within Nova Consumer Health and your employment will be governed by Nova Consumer's employment processes, programs, policies and benefit plans. Health. In such event, details of any planned changes will be provided to you by Nova Consumer Health at the appropriate time and in accordance with applicable law.

At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.

Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.

Our vision is to be the best-in-class Health & Wellness organization by leveraging the commercial strategy to deliver competitive advantage and value creation for the consumer, customer, and J&J. And as part of one of the largest and most diverse healthcare companies in the world, our brands leverage the company’s world-class research tools and scientific prowess to provide consumers across the globe with innovative consumer medicines, skin, baby, and essential health solutions.

You deserve to work in a place where you feel well and welcome.

**We are searching the best talent for**:
**Lead Computer Systems Validation LATAM - CONSUMER SJC (ID: 2206077325W)**

The Lead CSV Latin America is responsible for building and execution of quality into enterprise-wide systems, tools, services and infrastructure through the end-to
- end lifecycle (design, develop, implement, maintain, retire)
- The individual ensures company quality standards and regulatory requirements are met for the systems under scope of responsibility
- The role is responsible for planning, executing, coordinating, and maintaining the validation activities for the systems within their scope; including approval of SDLC validation documentation, release system implementation and/or changes for production use, providing computerized systems validation guidance and support to support team members in the execution of system base business activities, enhancements, and small projects.
- The individual reviews and approves SOP and WIs related to the systems within their scope and assists with incident management/CAPA and NCs for systems supported
- This position will support internal audits, Health Authority regulatory inspections and system periodic reviews

**Qualifications** Mandatory requirements**:

- A Bachelor’s degree in Computer Science, Information Systems, Business Administration, or another related field required; relevant experience may be substituted when appropriate; additional certifications a plus
- A minimum of 4-6 years of progressive industry experience, with direct experience in Computerized System Validation (CSV) in GxP environments
- Experience authoring or approving validation deliverables, Non-conformities, Change Requests, SOPs, Validation Plans and Reports
- Knowledge of Data Integrity, cGMP regulations related to CSV
- Experience providing CSV support in at least one of the following areas: ERP, Laboratory or Manufacturing systems, medical device software, infrastructure qualification, hosted platforms, emerging technologies (e.g. AI, ML, RPA) or externally facing digital assets (e.g. mobile apps, Websites that include both static and dynamic processing)

**Preferred requirements**

**Multi-lingual (Spanish and Portuguese)**
- Working knowledge of Quality Management Systems, PMO, SDLC, Testing, GAMP 5, and ITIL frameworks
- Ability to perform work with a high degree of independence in terms of self-management of a variety of tasks
- Solutions oriented, striving for new ways to accomplish goals and pragmatic advising in meeting compliance requirements
- Works effectively in a virtual team environment; comfortable collaborating and communicating with various cross-functional groups

**Location Consumer J&J SJC**

**Primary Location**
Brazil-São Paulo-São José dos Campos-Rod.Presidente Dutra, Km 154

**Organization**
J&J Brazil (7680)

**Job Function**
Quality

**Requisition ID**
2206077325W