Nc Capa Lead Qms

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

We are searching for the best talent for NC CAPA LEAD QMS to be in Sao Jose dos Campos, Brazil

Purpose:
The NC CAPA Lead, QMS - Technology Quality manages Technology Quality (TQ) staff and contractors performing activities for improving or establishing oversight for all IT Shared Services Non-conformance and CAPA investigations. This individual will provide compliance support and quality leadership to TS Operations, Engineering, and Q&C in the investigation, resolution and documentation of individual quality problems and trends. This position will report to the CAPA Leader and will also be responsible for monitoring the incident and problem management processes (Service Reliability) to identify events or trends that may require Non-conformance and CAPA investigations.

You will be responsible for:

- Day-to-day execution of Technology Quality (TQ) Nonconformance (NC) and Corrective Action and Preventative Action (CAPA) investigations
- Provide compliance support and quality input to TS Operations, Engineering, and Q&C in the investigation, resolution and documentation of individual quality problems and trends
- Provides input for process improvement efforts through feedback to other TQ pillar functions
- Partners with JJTS organization to support the identification of quality issues within incident & reliability tickets
- Creates NC Investigations and CAPA reports
- Provides feedback on compliance risks in Technology Services processes and procedures
- Provides input on the process procedures that meet operational, regulatory, and company policies
- Creates and modifies Quality System documentation inclusive of SOPs, WIs, Standards, and Guidelines
- Supports Inspection Readiness for the IT Incident/Problem/Reliability/NC/CAPA
- Communicates key messages and presentations to various cross-functional groups to gain support
- Identifies potential gaps with in-scope systems and processes, raises appropriate Non-Conformance, CAPA and drives remediation with business and IT alignment

**Qualifications**:
**Requirements**:

- A minimum of a Bachelor’s degree is required; a field in Computer Science, Information Systems, Life Science or another related field or advanced degree preferred.
- A minimum of 6 years of related professional experience is required.
- Experience with NC/CAPA programs along with Global teams across multiple geographies in the pharmaceutical/med device/biotech industry.
- Experience in Quality, Compliance, Continuous Improvement or Computerized System Validation activities is required.
- Strong QA, Compliance, or Technology skills with experience in Computerized System Validation in the pharmaceutical or medical device industry required.
- This position is located in Brazil and may require up to 10% international travel.