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Senior Manager External Supply - Pharma
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Biotechnology and Pharmaceutical organization, based in Schaffhausen Switzerland.
Our client is a worldwide producer of Pharmaceuticals and Medical Devices.
- In this role you provide Quality Assurance, Compliance and Technical Support for specific strategic external manufacturers with focus on biologics/parenteral pharmaceuticals on behalf of the EMEA region.
- As Senior Manager Supplier Quality you also provide QA support for technology transfer and improvement of existing manufacturing processes.
- You exercise quality oversight over a defined number of External Manufacturers.
- Build and maintain the relationship with QA counterparts of the External Manufacturers and other External Manufacturing stakeholders
- Assure smooth and compliant manufacturing operations from a QA point of view for the External Manufacturers (explicitly writing and maintaining Quality Agreements, planning, execution and follow up of audits, managing change control and supporting investigations)
- Pro-actively identifying risks and support resolution
- Act as Quality Person in escalation meetings
- Ensure that all relevant QA related concerns of the External Manufacturing Organization are raised at the correct level
- Support during regulatory inspections and make sure that the External Manufacturer is inspection ready
- Operate within a global framework with a globalized approach
- Due diligence audits of prospective new external manufacturers and writing of audit reports and follow-up documentation
- Bachelor or Master Degree in Pharmaceutics, Chemistry, Biology, Chemical or Pharmaceutical Engineering
- 10 years of experience in a FDA regulated pharmaceutical aseptic processing environment, with five years of experience in a relevant Quality Assurance role
- Broad understanding of all current pharmaceutical production methods (Sterile, tableting, semi solids)
- Familiar with the international GMP rules (EU, CFR, ICH, etc)
- Willing to travel (up to 30%)
- Able to work in a culturally diverse environment
- Experience with external manufacturing is desirable
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.