Head of Quality Management - Rare disease products

Head of Quality Management - Rare disease products

This is a great role for a professional to be involved in a senior management QA position for a global organisation. Working closely with the Senior VP, your role will involve ensuring the company's compliance with Quality Standards and its Quality System by being directly responsible for all aspects of the Quality Management System (QMS). In addition, a primary function will be for you to serve as the Responsible Person ("fachtechnisch verantwortliche Person") for Swiss Medic.

My client, a global small company focused on rare disease products is now looking for a key QA professional to develop and maintain the global quality framework.

By working in a small company directly with the Senior VP of Quality, Regulatory and Research and Development you will be part of the main decision makers within the organisation giving you the power to be able to actually influence the future of the business.

Main duties include:

* Conducts activities required as Responsible Person (RP) in Switzerland as related to our business operations and ensure compliance with all relevant Swiss laws and regulations
* Review of documents and release process required for production of APIs and products for commercial distribution
* Quality audits of suppliers, vendors, manufacturers and distribution services utilised for commercial APIs and products
* Ensures that the company maintains compliance with current GMP, GDP, GLP, as well as to all service providers involved in the manufacturing, testing, packaging and distribution of APIs and products
* Directs interaction with service providers during health authority inspections of their facilities
* Coordinating/preparing responses to health authorities when audit generates findings of deficiencies e.g. FDA Form 483, in conjunction with other relevant areas, e.g. Regulatory Affairs, CMC etc.
* Oversees the implementation and upgrade of Quality's electronic documentation system which houses company policies and procedures as well as controlled documents

My client is looking for people with a background in GMP within the pharmaceutical or biotech industry (ideally in rare diseases), together with FvP/QP (Qualified Person) experience and Quality Management. This is an English speaking environment and experience in EU is needed.

For a confidential discussion about quality assurance, then send your CV in Word format (I am unable to accept PDF's) to E.Cazacu@nonstop-recruitment.com or call me, Elena Cazacu, Quality Assurance Consultant for Switzerland.
NonStop Pharma is Nonstop Recruitment's longest running division with an ever growing number of consultants covering a wide range of niche specialisms across Europe. Owing to our breadth and depth of coverage we are well equipped to provide specialist support to a full range of services from large scale recruitment campaigns to executive searches and permanent to interim positions. For more information, see our website, http://www.nonstop-recruitment.com/ .
Also if you believe that these might not be the right opportunities for you but you know someone else who is looking for this kind of positions please feel free to refer them to us and you could gain € 250 in amazon vouchers if we successfully manage to place them.
Please note we can only accept applications from candidates who hold valid European Union passport and are able to work in Europe without visa sponsorship.
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