394643BR
**Quality Process & Engineering Manager**:
Italy
**About the role**
Ivrea, Italy (Hybrid) #LI Hybrid
We are seeking a Quality Process & Engineering Manager to establish, maintain and improve the engineering processes with respect to buildings, equipment, utilities and energy.
This role includes oversight of operational and validation activities and continuous process improvements.
This role will work directly with the Technical Research and Development (TRD) QA team and reports to the TRD Quality Head.
**Key Responsibilities**:
- Writing reviews/deciding on approval and release of GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
- Managing project related activities (e.g.
TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
- Supporting Project management functions as a project team member.
- Providing support to TRD line functions in GMP related topics as per area of responsibility.
- Complying with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.
).
**Commitment to Diversity & Inclusion**:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Role Requirements**
**Essential Requirements**:
- Degree in relevant field, or relevant business experience.
- Fluency in English & Italian (both written and oral).
- Communication skills to sufficiently address GMP and logistic related questions with line unit experts.
- Scientific, technical and regulatory knowledge.
- Basic knowledge of drug development.
- Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines.
- Good organizational skills.
**Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
**
**Division**
Development
**Business Unit**
QA GDD
**Work Location**
Colleretto Giacosa
**Company/Legal Entity**
AAA Italy Srl.
**Functional Area**
Quality
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No