Quality Assurance Manager

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Johnson & Johnson Consumer Health is recruiting for a **_Quality Assurance Manager_** to work in **_São José dos Campos._**

Position duties & responsibilities:

- Leads the implementation and administration of quality management system in accordance with applicable standards.
- Drive compliance with regulatory and company quality requirements for products, components, and raw materials.
- Handle and oversee CAPA program, including metrics, and execution and development of CAPA capabilities.
- Run and lead Complaints process and ensure complaint investigations are completed in a timely manner.
- Manage and oversee Field Actions and Stop Shipments.
- Review and approve quality systems documentation, including product disposition, manufacturing instructions, change controls, specifications, validation documentation and technical studies.
- Communicate business needs regarding procedures and processes for recording, evaluating, and reporting quality and reliability.
- Request data and metrics reports obtained from quality databases and files for inclusion in management reports.
- Examines results from management reviews, third party inspections, and internal audits, and approves proposed corrective actions.
- Partners with compliance and operations partners to ensure site inspection readiness.
- Actively lead team by setting standards for performance, performing assessments, providing feedback, delivering effective communications, and promoting employee motivation.
- Acts as a technical/quality reference to any quality topic.
- Technical Regulatory Affairs oversee connecting with Regulatory Affairs area.

**Qualifications**
- A Bachelor’s Degree in Pharmacist is required. A MBA is an asset.
- A minimum of 8 years’ quality experience in a GMP and/or ISO regulated industry is required. Pharmaceutical industry experience is highly preferred. Additive Manufacturing experience is an asset.
- A minimum of 4 years of direct people management experience is required with a demonstrated track record for coaching, talent development, and performance management. - Demonstrated ability to work across all levels including executive management and Manufacturing associates is required.
- Product/Process Risk Management experience is required.
- Experience managing CAPA and Audits is required.
- The ability to perform “hands on” troubleshooting and problem solving and ability to take initiative with an innovative approach in a fast-paced, changing business environment is required.
- Experience working in manufacturing/operations is preferred.
- Advanced Technical Training and/or experience using Statistics, Lean, and Six Sigma Methodologies is preferred, including Measurement System Analysis, SPC, DOEs, Reliability, etc. is preferred.
- Direct interaction and experience with ANVISA or third-party inspectors during investigations is preferred.
- The position will be based in São Jose dos Campos - Brazil.

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

**Organization**
Janssen Cilag Farmaceutica Ltda. (7585)

**Job Function**
Quality

**Requisition ID**
2206075774W