Manager External Quality

3 giorni fa

Latina, Italia Johnson & Johnson Family of Companies A tempo pieno

**Manager External Quality - CAR-T**

Do you want to join Johnson & Johnson, one of the largest health care companies in the world, do you have a passion for quality and for saving the life of many of our patients, then this role is what you are looking for Janssen is recruiting for a Manager External Quality, located in Europe. This position will provide Quality Assurance support for multiple sites (hospitals, cryopreservation centers ). Assist or conduct audits, follow-up on the development of corrective action plans and supervise in the implementation. Contribute to the oversight of supply chain activities and execution of quality systems in support of apheresis, cryopreservation, and storage of clinical and commercial materials and products.

**Key Responsibilities**:

- Participate and lead audits of Hospitals and Cryopreservation Centers, and their third-party Suppliers (when applicable)
- Partner to develop corrective action plans and monitor implementation
- Be responsible for the overall development, implementation, and execution of quality systems. Conduct investigations, perform customary audits, collect data, analyze trends, and prepare reports as required.
- The position will negotiate and review all relevant Quality Agreements between Janssen and the sites. The position assures implementation and maintenance of these Quality Agreements
- Assists with regulatory inspections and provides follow up on regulatory commitments.
- Coordinate and provide concurrences on deviations, change controls, and product quality complaints.
- Provide Quality oversight on executed batch record review and batch release process
- Routinely provide metrics for management review

**Qualifications**
Qualifications**
**Education**:

- Bachelor degree with minimum of 3 years in health care industry

**Experience and Skills**:
**Required**:

- Extensive knowledge of Quality Assurance, Quality Control and Compliance
- Ability to work with multiple and/or complex External Manufacturers
- Ability to operate with a minimum of supervision
- Ability to take ownership for and lead the resolution of complex Quality and Compliance issues
- Ability to travel for up to 50% in Europe.

**Preferred**:

- Experience in API and Finished Product manufacturing is preferred
- Experience in Pharmaceutical Manufacturing
- Experience in Good Tissue Practices

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

**Primary Location**
Belgium-Antwerp-Beerse
- **Other Locations**
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Italy-Lazio-Latina, Europe/Middle East/Africa-Ireland-Cork-Cork, Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen
**Organization**
Janssen Pharmaceutica N.V. (7555)
**Job Function**
Quality
**Requisition ID**
2206018658W

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