Operations Manager

This is an exciting new role with a Clinical Distribution and Packaging Company who have opened a brand new facility based in Schiphol. You will be responsible for the management of the Operation group and ensuring overall GXP compliance with all procedures affiliated with receiving, storing, label production, packaging, distributing, returns processing, disposition of clinical supplies and project coordination. The role will also have responsibility for capturing the future packaging / labelling / distribution needs of the Netherlands facility and the associated staff requirements.

Responsibilities

• Collaborates and liaises with the VP of Operations and Distribution Project Managers in the US.
• Initiates and/or participate in preliminary discussions with assigned client proposals in order to devise a plan for the distribution of study materials.
• Acts as the liaison between the client and internal departments for the requisition of required documentation (i.e. Certificates of Analysis, MSDS, Certificate of Release, temperature excursion criteria for temperature-controlled products, etc.)
• Procure materials for use in the distribution process such as temperature monitoring devices, insulated shippers, gel packs, etc.
• Guide client in selection of temperature monitoring devices and/or packing materials based on temperature sensitivity of the product.
• Responsible for the interpretation and preparation of preliminary Clinical Supply Shipment Invoice format, databases, spreadsheets, packing configurations and processing directives to meet proposal specific shipment requirements.
• Responsible for setting up spreadsheets to track inventory, item codes and shipments to meet SOPs and GDP/GMP requirements.
• Liaises with the Client and Project Manager to devise Distribution Strategy, Distribution Protocols and associated documents, including IWRS considerations / activities to be performed by staff.

Qualifications

• Related bachelor's degree or equivalent
• Excellent interpersonal skills
• Excellent reading and writing skills
• Excellent communication skills
• English literacy
• Excellent mathematical skills
• Computer literacy skills
• Attention to detail
• Strong problem-solving skills
• Knowledge of EU GMP and GDP
• Familiarity with the pharmaceutical industry
• Familiarity with the concept of placebo controlled randomized clinical trials, and the importance of distribution activities associated with the blinded status of the trial

If of interest please apply with a copy of your latest CV. Applications will be processed over the next 2 weeks.