Quality Assurance Ops Lead — Hybrid & Impact

Novartis Italia; Ivrea; In loco; EUR 58.000 - 108.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid working options

14 weeks paid parental leave

Insurance plans

Retirement plans

Descrizione del lavoro

Novartis Italia in Ivrea, Italy is seeking a Quality Assurance Operations Lead to ensure released products meet GMP, FDA, and regulatory standards and to provide QA oversight of manufacturing activities. You will lead QA Operations, manage resources, approve quality processes, support audits, and drive continuous improvement across the site.

The role requires a scientific degree and 5+ years in pharma QA, fluency in Italian and English, and offers hybrid work, competitive benefits, and a salary

Competenze

• 5+ years in the pharmaceutical industry with QA Operations experience.
• Strong knowledge of cGMP regulations and quality standards.
• Experience with aseptic manufacturing processes.
• Excellent organizational skills and attention to detail.
• Strong communication and collaboration abilities; ability to work with urgency.
• Fluent in Italian and English (written and spoken).

Mansioni

• Lead implementation and continuous improvement of quality standards compliance.
• Oversee QA Operations activities: product release, documentation, SOPs, training, resource planning, shift organization for QPs and QA Officers.
• Ensure QA oversight of manufacturing operations, qualification, calibration, revalidation, process validation, cleaning validation, equipment qualification, and new projects requiring QA Operations support.
• Manage and approve quality processes: OOS, OOT, OOE, deviations, change controls, CAPA, complaints, recalls, investigations.
• Ensure timely escalation and communication of quality and cGMP issues to stakeholders and authorities when required.
• Support audits, inspections, and quality reviews by participating in audits and annual reviews.
• Monitor quality performance and drive improvements with Site Management, Quality, Quality Control, and Production leaders.
• Provide QA support to commercial operations with environmental, safety, order, cleanliness, internal communication, and external communication requirements.

Conoscenze

QA Operations

cGMP knowledge

Aseptic processing

Organizational skills

Communication & collaboration

English & Italian fluency

Formazione

Degree in Pharmacy, Chemistry or Biology

Descrizione del lavoro

Novartis Italia in Ivrea, Italy is seeking a Quality Assurance Operations Lead to ensure released products meet GMP, FDA, and regulatory standards and to provide QA oversight of manufacturing activities. You will lead QA Operations, manage resources, approve quality processes, support audits, and drive continuous improvement across the site.

The role requires a scientific degree and 5+ years in pharma QA, fluency in Italian and English, and offers hybrid work, competitive benefits, and a salary