Senior Clinical QA Manager (d/f/m)

Job Description

Industry: Pharmaceutical Manufacturing
Seniority for this role: Mid-Senior level
Job Description Sandoz, of which Lek is also a part, is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz and Lek associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz and Lek! Your Key Responsibilities Your responsibilities include, but not limited to: Set up, implementation and maintenance of the Sandoz Development Center (SDC) Clinical Quality Management System, to ensure compliance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), local regulations, requirements, and company standards. Support of the Clinical Operations function on implementation and proper execution of GCP/ GLP quality related activities, including Critical Quality Attributes (CQA) support for clinical development activities. Lead / participate in GCP audits and inspections, as well as ensure audit and inspection readiness. Oversight of SSM GCP ESPs (external clinical providers) to ensure their proper qualification according international and Company GCP standards, including qualification visits as and when required. Ensure the appropriate trainings and awareness of quality and compliance requirements and the SDCs Quality management System. Collaborate with other Product Development/SDCs departments involved in study activities. What You Will Bring To The Role Degree in Natural Science or comparable natural scientific education. At least 5 years’ experience in Clinical Operations or Clinical Quality Management Good knowledge of global regulatory framework, GCP experience, knowledge of EU and FDA and local regulations, ICH requirements and common quality standards. Fluent knowledge of English language (written and spoken). You’ll Receive Employment at the most reputable employer in Slovenia offers Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), Unlimited learning and development opportunities. Possible job locations: Slovenia (Ljubljana) We offer permanent contract with 6months of probation period . You are kindly invited to submit your application in English language, including CV, by 19 January 2025. Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! The future is ours to shape! Commitment To Diversity & Inclusion Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool #Sandoz Show more Show less