External Operations Manager for Clinical Distribution (f/m/o) 100%

For our client, a renowned pharmaceutical company based in Basel, we are seeking a:

External Operations Manager for Clinical Distribution (f/m/o) 100%

Our Client:

300+ associates. A team of globally collaborative colleagues at the ‘Global Clinical Supply (GCS)’ function to support clinical trials from Phase 1 to approval and be a key interface between Technical Research & Development (TRD) teams and the Clinical teams!

At GCS, we aspire to become a data and digital-powered, resourceful, agile organization to deliver more products to more patients efficiently, through empowered and highly capable teams.

General Role Description:

Responsible for operational execution of clinical distribution with the focus on the external part of the clinical trial distribution supply chain. Oversee all outsourcing activities related to clinical distribution and functions as the key business partner interface with external contractors and ensure operational excellence within the CMO network, ensuring the delivery of high productivity, quality and cost-effectiveness. Operational end-to-end responsibility for assigned activity. Lead and manage projects and global distribution network activities and participate in cross-functional teams.

Daily Tasks

  • Assesses risks of the particular distribution strategy and provides guidance to other functions for distribution supply chain setup optimization. Advises GCS Study Team on all relevant elements of clinical distribution to ensure optimal usage of available capacity and budget. Drives the optimization of the general supply chain planning for development projects.
  • Manages order alignment with GCS Study team members to coordinate distribution order preparation and to ensure proactive resolution of any distribution order-related questions.
  • Acts as the key business partner for operational interactions with the Vendors. Reviews the vendor capacity, resource planning and distribution tracker.
  • Is responsible for the setup, management and development of the external distribution network
  • Interacts with internal functions and distribution vendor to flag potential issues or bottlenecks due to high demands, seasonal situations or local/regional issues.
  • Manages deviations occurring at external vendors and escalates high-level issues/bottlenecks to the relevant internal GCS stakeholders and external partners
  • Monitors and analyses vendor performance with pre-defined KPIs and collaborates with vendor to identify process optimizations and ensures timely follow-up and completion of actions
  • Liaises with GCS counterparts to review project status.
  • Provides and analyses reports on various distribution as well as finance-related topics
  • Has operational end-to-end responsibility for assigned supply activities. Leads and manages projects of different complexity and local network activities and participates in cross-functional teams.
  • Produces, packages and manufactures drugs to be used in clinical trials. Responsible for distribution, warehousing, transportation, packaging, randomization, blinding, and labeling of material for clinical trials in conformity with guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP).
  • Has operational end to end responsibility for assigned supply activity. Leads and manages demanding projects and network activities and participates in cross-functional teams.

KPI:

  • Adherence to costs, quality (GMP), quantity, and timelines for all assigned tasks/projects
  • Compliance with internal standards, in particular, ethics, health, safety, and environment (HSE), and information security (ISEC) standards.

Requirements

  • Fluent in English and German, written and spoken
  • Degree in science, engineering or equivalent
  • >5 years of practical experience in chemical / pharmaceutical industry or in field of expertise. Good knowledge about the Drug Development process. Project management preferably in Distribution, good organization and planning skills. Knowledge of relevant regulations (e.g. GMP, HSE etc.) and internal specific standards.
  • Software skills: SAP, MS Office
  • Soft skills: Very good communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams.
  • Ideal previous experience: Vendor management, clinical distribution, project management, clinical trials, Pharma or CMO

General Information: 

  • Start Date:   ASAP
  • End Date:   16/07/2023
  • City:   Basel 
  • home office possible in alignment with the business need, manager and the team, as well cross border regulations

Marilu Mercedes
Marilu Mercedes
Telefon: 058 255 31 04

Jetzt online bewerben