Head of Quality Assurance

SUANFARMA is looking for a Head of Quality Assurance to join our team in Rovereto (TN), Italy. The Head of Quality Assurance, as part of the site's Quality Unit, shall ensure that all quality systems comply with Suanfarma and International guidelines, that regulatory documentation is updated and that all GxP‑impacting IT systems with impact on GxP are properly used and validated. Key Responsibilities Lead and coordinate all the activities of the Quality Assurance and Regulatory Team. Review batch records. Review and approve process and product‑related processes and products. Manage changes in collaboration with Regulatory Affairs. Issue the Site Validation Master Plan. Issue the Annual Product Review. Issue the Quality Plan and Quality Report. Support other functions on quality topics. Arrange and plan the annual GMP training courses. Arrange and execute suppliers external audits for the Site and for the Company. Arrange and execute internal audits. Support the preparation of audits by external regulatory bodies with close collaboration with the Audit Coordinator. Manage the Quality agreements with suppliers. Manage documentation, change control, deviations, complaints and CAPAs together with the QA team. Issue regulatory documentation in order to ensure regulatory compliance. Support and actively collaborate for achievement of Company projects and tasks. Reporting Line reports to: Head of Quality Unit Profile And Qualifications Min. 5 years experience in a similar role or in a senior role in Quality Assurance in a pharmaceutical company. Master's degree in Computer Science, Chemical Engineering, Chemistry, Pharmacy or equivalent. Fluency in Italian and English Deep knowledge of cGMPs, Regulatory guidelines, Annex 11, Annex 15 and Code of Federal Regulations, Computerized Systems Validation, Project management, Vendor audits and Change control. Strong interpersonal, project management, change management, problem‑solving and analytical skills. Continuous improvement mindset. Preferred: Qualified person qualification and SAP proficiency. Location and Travel This position is based in Rovereto (TN), Italy. Occasional travels (up to 10% of working time). Who We Are SUANFARMA Italia is an international leader in the development, production, and distribution of active pharmaceutical ingredients for human and animal health. We are part of the multinational SUANFARMA Group, headquartered in Madrid, Spain, operating in over 70 countries worldwide and serving a portfolio of more than 3,000 global clients. The lives of over 500,000 patients depend on the anti‑rejection drugs manufactured at our facility, and every year, with our human‑use antibiotic, we help safeguard the health of more than 200 million patients. Since our foundation in the late 1960s, we have been committed to two parallel priorities: well‑being and innovation. We develop new technologies to deliver innovative products while placing people at the centre of everything we do. Our philosophy is rooted in continuous improvement across all business areas, ensuring we remain an organisation truly focused on customer needs. Our mission has always been to “improve people’s lives by providing customers in need with high‑quality medicines at affordable prices”. To achieve this goal, we base our daily operations on quality and sustainability—of products, processes, and work practices—fully aware of our social responsibility. Why Work With Us People’s well‑being is at the heart of our philosophy, including life within the company. We care about individuals, their safety, and their needs. We want our employees to work in an environment where they feel valued and can fully express their talent. We offer: A safe and positive workplace. An informal leadership style based on listening, dialogue, and employee development. A comprehensive package of welfare initiatives and benefits. Competitive market salaries. A passionate and collaborative team where everyone can contribute to discovering, seizing, and implementing opportunities for innovation and improvement. All of this makes SUANFARMA Italia a company of excellence with a modern approach to human resource management. SUANFARMA Italia is an equal opportunity employer. This job posting is also open to candidates with disabilities and to those belonging to the protected categories under Articles 1 and 18 of Law 68/99. #J-18808-Ljbffr