External Operations Manager
Vor 2 Tagen
More than 500 This is the number of clinical trials, which are managed by the Global Drug Development organization of Novartis.
- The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.
- The External Operations Manager (EOM) is responsible for planning, execution and distribution activities performed at external vendors. The EOM oversees all outsourcing activities including packaging, distribution and functions as the key business partner interface with external vendors and ensures operational excellence within the CMO network, ensuring the delivery of high productivity, quality and cost effectiveness. Execute and monitor timely activities related to assigned area of responsibility under the guidance and accountability of more senior associates.
- Your key responsibilities will include but are not limited to:
- Manages all applicable finance activities, including Request for Proposal (RFP) for bidding & vendor selection, Grants, Purchase Orders (PO), invoice approval and tracking financial metrics.
- Provides guidance to the CTSM for packaging design optimization. Advises GCS Study Team on packaging designs to ensure optimal usage of available capacity and budget.
- Manages Order Alignment with Global Clinical Supply (GCS) Study team members to coordinate packaging order preparation and to ensure proactive resolution of any packaging order related question
- 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.
- Coordinates material routing and inventory management of all drug product, primary packed materials, packaging components and labels for packaging orders at external vendors.
- Liaises with CTSM/SCM on a regular basis to create packaging orders based on the project specific requirements
- Interacts with the SCM and CTSM to flag potential issues or bottlenecks due to availability of PP/DP or locally/ regionally sources items at the respective local hub
- Ensures most cost efficient material flow, minimizing waste and allowing the flexibility to accommodate the changing demand.
- Manages all packaging activities executed by vendors and ensures agreed milestones and cost are met and creates packaging orders in SAP
- Coordinates logistic documents for facilitating import requirements
- Manages deviations occurring at external vendors and escalates high level issues/bottlenecks to the relevant internal GCS stakeholders and external partners
- Participates or supports external inspections and audits together with TRD QA (and GCP QA where applicable) to assess packaging contractor capabilities
- Monitors vendor performance with pre-defined KPIs and collaborates with vendor to identify process optimizations and ensures timely follow up and completion of actions
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
- What you'll bring to the role:
- Degree in science, engineering, or equivalent
- Proficient in English
- 5 years of practical experience in chemical / pharmaceutical industry or > 3 years of experience in field of expertise
- Basic project management, good organization and planning skills
- Knowledge of relevant regulations (e.g., GMP, HSE etc.)
- Problem-solving, idea generation and presentation skills
- Good communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams
- Fundamental Leadership skills.
**Division**
- Global Drug Development
**Business Unit**
- TECHNICAL R & D GDD
**Country**
- Switzerland
**Work Location**
- Basel
**Company/Legal Entity**
- Novartis Pharma AG
**Functional Area**
- Research & Development
**Job Type**
- Full Time
**Employment Type**
- Regular
**Shift Work**
- No
**Early Talent**
- No
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