Head of Tech Ops Medison EU
About The Position
Medison stands as a distinctive global pharmaceutical company, driven by an unwavering purpose: to deliver groundbreaking therapies to patients suffering from rare and severe diseases across international markets. We believe that all patients, wherever they are in the world, have the right to get access to the best available novel treatments, and we are here to make this happen. As we continue our global expansion, we seek individuals who share our passion and principles, are eager to build and make a difference.
We are patient-centric, innovative, agile, and always ahead.
Come and join our growing team!
Responsibilities
- Leads the Tech Ops team and functions in EPM
- Provide strategic direction and guidance for the local Supply Chain, Quality Assurance, PV and Regulatory functions
- Assure end-to-end harmonization of quality processes and systems including risk and GMP core management, and regulatory compliance with worldwide requirements.
- Ensure local teams execute on timely preparation and submission of marketing approvals and post approval variations in compliance with local market regulations.
- Leads logistics strategy and oversight of supply chain management activities in Medison including delivery of products to market within defined regulatory, legal, quality and cost standards
- Partner with Commercial and Finance counterparts for launch management, commercial supply chain/product demand forecasts, inventory management and costs
- Work with Tech Ops team leads to develop operational priorities, budgets, and to allocate resources and workloads
- Coordinate Medison EPM Purchase Order processes with Finance
- Support local CMs and BD to assist in the development and maintenance of ongoing contracts with all suppliers
- Ensure necessary audits (supply chain, regulatory and quality) are performed in accordance with the manufacturers/MAH’s requirements as stipulated by contracts
- Support the Regulatory and QA Managers in activities such as audits, regulatory agency inspections, or product recalls, labelling & packaging requirements of our partners
- Responsible for selecting / procuring suppliers and ensuring each chosen supplier successfully completes due-diligence and continues to operate in accordance with the terms & conditions laid out in the contracts
- Responsible for Medison’s 3rd party warehouse or distribution site(s) and ensure that each site adheres to all necessary local laws and obligations
- Responsible for any warehousing or distribution agreements that Medison will hold related to our operations.
- Routinely communicate with the GM, VP Medison EPM and local Country Managers to directly ensure operations requirements and planning is executed and adapted to align with the new business development targets and lifecycle phase of the products.
- Demonstrate effective communication, collaboration and leadership with all necessary stakeholders and partners to maximize ability to execute objectives in timely manner and with efficiency.
Requirements
- 10+ years of related pharmaceutical, biotech experience with excellent reputation in the industry
- Experience in Supply Chain required
- Experience / strong interaction in Quality and Regulatory is an advantage
- Thorough knowledge of operations processes for innovative pharmaceutical / biotech markets
- Prior management level experience with demonstrated ability to develop and mentor staff
- Experience managing and interfacing effectively with CEO Staff level stakeholders, negotiating and synthesizing messages
- Experience in a large innovative healthcare organization and / or healthcare related 3PL preferred
- Experience working with multinational staff and organizations
- Great negotiations skills