Quality Assurance Operation Manager

3 giorni fa

Latina, Italia Johnson & Johnson A tempo pieno

Janssen is recruiting for a **QA Operation Manager **. This position will be based in Latina site, the most innovative drug product (DP) manufacturing site in the Janssen Supply Chain Small Molecule Platform.

**Key responsibilities**:

- Lead Investigation Team supporting the Site in handling non conformance and defining adequate corrective actions.
- Lead Complaints Team in investigating internal and market complaints. Connect with Commercial Affiliates and Global Pharmacovigilance
- Lead Batch Record Review Team to assure product release on the market according to pre-defined timeline
- Assure the implementation of new regulatory requirement through the evaluation of new or modified global procedures and though connection with Global Compliance Teams
- Connect with Global Supplier Qualification team and assure oversight of supplier related activities at the Site
- Raise criticalities to the upper management through critical Company meetings
- Actively participate to Regulatory and Customer Inspections
- Connect with internal and external customers to share practices and find opportunities for continuous improvement
- Assure creation of competencies for people in the team including new technologies and digitalization
- Assure performance supervising through Site critical metric evaluation
- Participate to the discussion on budget and assure the adequacy of the resources
- Assure Safety rules are followed and notify potential risks through company process

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

- Master Degree in Chemistry, Chemistry and Pharmaceutical technology, Engineering, Biology

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

- Minimum 10 years of working experience
- Excellent English knowledge
- Experience in people management
- Proficiency in GMP and in quality investigations
- Excellent ability to work in team and to connect with different organizations and different roles in the Company

**Preferred**:

- Previous experience in pharmaceutical environment
- Experience in multicultural environments

**Other**:

- Required 10% Travel national or international

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.

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