2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz... are you ready to make a difference?
Your Key Responsibilities:
Your responsibilities include, but not limited to:
• Build a strong Compliance culture within the Biopharmaceuticals Technical Development (BTD) organization, aligned with Sandoz global Quality and Data & Systems Governance.
• Drive a culture of quality in development implementing the strategy, mission and vision of BTD within Sandoz Global Development.
• Be responsible for good documentation practices and compliance within the technical development units in line with Health Authorities’ requirements. Ensure all internal compliance standards are met with full adherence to the principles of Data Integrity for people, processes and equipment.
• Provide robust and clear compliance governance & oversight in areas of development laboratory activities proactively supporting internal key stakeholders to ensure compliance to the company internal development quality standards.
• Identify, shape and lead / coordinate continuous improvement initiatives (including work streams), and ensure that areas identified as weaknesses are properly being addressed and sustainably and lastingly improved.
• Provide comprehensive advice as a go-to person on a wide range of compliance and data integrity topics, prepare line functions for audits (authorities or internal) prepare and perform inspection readiness checks, gap analysis and action lists, and guide implementation teams on the shop floor
• Coordinate collection, reporting and presenting key performance indicators for compliance & Data Integrity
• Initiate, lead and influence new compliance enabling programs, as well as identify and address complex issues across line functions within Technical Development.
• Evaluate and implement new approaches and methodology to identify and solve issues, in close alignment with other expert departments
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you’ll bring to the role:
• Ph.D. in a technical discipline (4+ years of experience) or Degree in Life Science discipline (8+ years of experience).
• Successfully demonstrated several years (minimum of 3 years) of directly related experience as Compliance Lead or equivalent, preferably in the field of technical development of Biologics/biosimilars.
• Fluent knowledge of English (spoken and written).
• Deep understanding of processes in technical development of Biopharmaceuticals.
• Thorough knowledge of guidelines that are relevant for biopharmaceutical and biosimilar development.
• Strong leadership, coaching and mentoring skills, as well as advanced communication and presentation skills.
• Strong track record of innovation, creativity, problem solving and continuous improvement in projects.
• Experience in preparation and execution of audits by authorities or customers
• Strong track record of major contributions to biopharmaceutical / preferably biosimilar development projectsand strategic activities / improvement projects in the field of quality and compliance, data integrity and data management.
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious 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 teams 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