External Operations Manager

Summary

About the role: The External Operation Manager (EOM) manages all external activities related to clinical supply (packaging, labeling and distribution) and acts as the main business partner interface with external vendors and ensures operational excellence within the network of Contract Manufacturing Organizations (CMOs), delivering high productivity, quality and cost efficiency. The EOM will have a Global role in setting up operations responsible for planning, execution and distribution activities performed at external vendors. Has operational end to end responsibility for assigned activity. Leads and manages all project and local network activities and participates in cross-functional teams. The Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster. Our world-class Global Clinical Supply Organization is able to deliver the right drug to the right patient at the right time. We collaborate with other Novartis groups to support clinical trials around the world to meet the needs of our patients. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. Apply today and welcome to where we thrive together!

About the Role

Key Responsibilities:

• Acts as the key business partner for operational interactions with the Vendors. Reviews the vendor capacity, resource planning and distribution tracker and verifies this with the study requirements to ensure the study timelines and specifications are met.
• Manages deviations occurring at external vendors and escalates high level issues/bottlenecks to the relevant internal GCS stakeholders and external partners and other compliance related tasks involved with maintaining qualification status of the vendor
• Liaises with Comparator Sourcing Supply Lead and internal GCS study team (with Clinical Trial Supply Manager and Comparator Sourcing Supply Lead) on a regular basis to create orders based on the project specific requirements.
  + ensure operational responsiveness to study dynamics.
• Ensures most cost-efficient material flow, minimizing waste and allowing the flexibility to accommodate the changing demand.
• Participates or supports external inspections and audits together with Technical Research & Development (TRD) QA (and Good Clinical Practice (GCP) QA where applicable) to assess contractor capabilities.
• Being sub-process owner in GCS, drives innovation in the areas of process simplification and cost reduction.
• Contributes to productivity targets by continuously improve processes in own area of expertise.
• Liaises with GCS counterparts to review project status.
• Monitors vendor performance with pre-defined KPIs and collaborates with vendor to identify process optimizations and ensures timely follow up and completion of actions.

Essential Requirements:

• Degree in science, engineering or equivalent.

• >5 years of practical experience in chemical / pharmaceutical industry or > 3 years of experience in field of expertise
• Good knowledge about the Drug Development process
• Basic project management, good organization and planning skills
• Knowledge of Good Manufacturing Practices and Health, Safety & Environment (GMP & HSE) regulations.
• Very good communication, Fundamental Leadership, negotiation and interpersonal skills and the ability to work in interdisciplinary teams.

Desirable Requirements:

• Degree in Science
• Distribution experience in Pharma

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. Level 4: In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is €60,212.18/ year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: