R&d Quality Manager

Novartis; Ivrea; In loco; EUR 40.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Quality Assurance expert in Ivrea, Italy. The role involves ensuring compliance with regulatory and quality standards, managing QA projects, and driving process improvements. Candidates should have a relevant degree and a minimum of 5 years in similar roles, with strong communication and regulatory knowledge being essential.

Servizi

Commitment to Diversity and Inclusion

Competenze

• Minimum 5 years of experience in pharmaceutical companies in equivalent roles.
• Fluency in English (verbal and written).
• Detailed knowledge of cGMP.

Mansioni

• Provide quality assurance expertise to ensure compliance with regulatory requirements.
• Review and approve GMP-relevant deliverables.
• Drive continuous quality improvements for manufacturing.

Conoscenze

Quality Assurance

Collaboration

Communication

Organizational Skills

Regulatory Knowledge

Formazione

Degree in Pharmacy, Biology, Chemistry, Engineering or equivalent

Descrizione del lavoro

• Provide quality assurance expertise, guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards. Manage projects, including Quality Plan initiatives, and processes that support quality objectives to assure their compliance with GxP regulations.
• About the Role
• Key responsibilities
• Support discipline / service provision individually or within a team; provide functional expertise to QA / Line Units as needed.
• Review, approve, and release GMP-relevant deliverables and tools to ensure cGMP compliance.
• Manage project-related activities (e.g., process / quality initiatives, facility upgrades, IT validation) as per responsibility.
• Ensure compliance with internal / external quality and safety guidelines (e.g., GMP, SOPs, Quality Manual).
• Drive continuous quality improvements for manufacturing, collaborating with production, engineering, and supply chain.
• Oversee qualification / validation of processes, equipment, facilities, and software for GMP use.
• Review and approve GMP documents, including URS, IQ / OQ / PQ, Change Controls, CAPAs, and SOPs.
• Support inspection preparations and maintain oversight of external maintenance and qualification activities.
• Degree in Pharmacy, Biology, Chemistry, Engineering, or equivalent.
• Fluency in English (verbal and written).
• Strong awareness of quality issues and urgency in task completion.
• Open and clear collaboration and communication skills.
• Scientific, technical, and regulatory knowledge in the specific area, with basic understanding of drug development.
• Detailed knowledge of cGMP and familiarity with safety / environmental regulations.
• Minimum 5 years of experience in pharmaceutical companies in equivalent roles.
• Strong organizational skills.

You will receive : You can find everything you need to know about our benefits and rewards in the Novartis Life

• Commitment to Diversity and 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

Location

Italy

Site

Company / Legal Entity

IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.