Job Description Summary
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.
Job Description
Key Responsibilities:
- 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 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.
Essential Requirements:
- 4 to 6 years of practical experience in chemical / pharmaceutical industry or > 3 years of experience in field of expertise, with Degree in science, engineering or equivalent.
- Apprenticeship or formal education in a logistical, technical or related business area
- Basic project management, good organization and planning skills
- Good knowledge of HSE/GMP standards and processes. Problem-solving and idea generation skills
- Good presentation skills. Fundamental Leadership skills.
- Good communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams.
Skills Desired
Continual Improvement Process, Master Data, Materials Management, Production Planning, Waterfall Model