SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Salary: EUR 57,900 - 107,500 / annual
DTX Pharma, a Novartis Company, seeks a Quality Assurance Operations Lead based in Ivrea, Italy. This role is responsible for ensuring the release of sterile injectable products manufactured in full compliance with GMP, FDA, AIFA, Novartis Quality Manual, and applicable regulatory standards.
Key responsibilities include leading the implementation and continuous improvement of quality compliance standards while fostering a strong quality culture across the organization. You will oversee QA Operations activities including product release, documentation management, SOP approval, training, resource planning, and professional development of team members. The role requires managing human and technical resources within the QA Operations department and ensuring effective QA support for the site's commercial operations.
You will ensure quality oversight of manufacturing operations, maintenance, qualification, calibration, revalidation, process validation, cleaning validation, equipment qualification, and new projects requiring QA support. Responsibilities include managing and approving quality processes such as out-of-specification (OOS), out-of-trend (OOT), deviations, change controls, CAPA, complaints, recalls, returns, and investigations in accordance with cGMP and SOPs.
The position requires timely escalation and communication of quality and cGMP issues, non-conformities, and product-impacting incidents to relevant internal stakeholders and competent authorities when required. You will support audits, inspections, and quality reviews by participating in authority and corporate audits, annual self-inspection planning, and Annual Product Quality Review preparation.
Monitoring and driving quality performance through tracking assigned indicators, ensuring timely project completion, and supporting business continuity in collaboration with Site Management, Quality, Quality Control, and Production leaders are essential. The role also involves providing QA support to commercial operations while ensuring compliance with environmental, safety, and communication requirements.
Required qualifications include a scientific degree in Pharmacy, Chemistry, or Biology; 5+ years of pharmaceutical industry experience with strong QA Operations knowledge; solid understanding of cGMP regulations and pharmaceutical quality standards; knowledge of aseptic processes and manufacturing practices; excellent organizational skills and attention to detail; strong communication and collaboration abilities; and fluency in Italian and English (written and spoken). Experience as a Qualified Person in high-tech production environments is highly valued.
