Job ID: 12536

Person responsible (FvP) and Teamlead Quality

Entourage is a life sciences consultancy headquartered in Munich with additional offices in Basel, Milan and Boston. The company has a multidisciplinary team of over 180 industry-experienced consultants who work closely with market leaders in the pharmaceutical and medical device industries to develop customized solutions. Through its unique hybrid approach, combining project and management consulting, Entourage is able to offer its clients customized solutions in the life sciences sector.

Become part of the Entourage team of experts and take on a leadership role in pharmaceutical quality assurance!

For our international client, we are looking for a committed personality as a specialist responsible person (FvP) and Teamlead Quality at the Frauenfeld location - with the possibility of working from home.

In this key role, you will work directly with our client and their European country organizations to ensure the highest quality standards. You will use your expertise to proactively optimize quality systems and lead a team of specialists.

You can expect an exciting, responsible position with scope to shape your own vision in a dynamic environment.

Entourage. Job offer.

Place: Frauenfeld

Job type.

Project Consulting

Your tasks.

  • Contact person for authorities for all pharmaceutical, GDP and GMP-related matters
  • Ensuring compliance with local regulations and international GDP/GMP requirements as well as relevant legal and ethical standards of the authorities and the company
  • Participation in the definition, implementation and maintenance of a local quality system that applies primarily to Swissmedic-regulated activities in connection with the import and distribution of products
  • Maintaining and updating all required site licenses for country activities
  • Taking all necessary measures to ensure the quality of the products and patient safety
  • Decision on market release/rejection of medicinal product batches
  • Carrying out recalls and notifications to Swissmedic's market surveillance in collaboration with other local departments and the global quality function
  • Approval of product quality reviews
  • Management of the quality team in Switzerland (1 person) and in Bulgaria (2 - 3 employees)
  • Management and support of inspections by the therapeutic products inspectorates and GxP-related audits
  • Implementation of external audits
  • Management of product-related risks (identification, assessment, control, communication)
  • Implementation of narcotics controls in cooperation with distribution centers
  • Ensuring an appropriate procedure for the protection of products (counterfeiting) and for dealing with issues of parallel trade

Your requirement profile.

  • University degree in pharmacy, medicine, chemistry or biosciences
  • More than 5 years of experience in the pharmaceutical industry in a GxP-related environment
  • Experience and knowledge as FvP in Switzerland
  • High quality awareness, sound knowledge of Swiss legislation and in-depth knowledge of EU GMP, GDP and narcotics
  • Experience in the management of GxP audits desirable
  • TrackWise, eDMS and/or SAP knowledge an advantage
  • Fluency in German and English, knowledge of French an advantage

Advantages.

  • A motivated and informal team with the support of a strong international company
  • Independent work with a high level of personal responsibility
  • Flat hierarchies and fast decision-making processes
  • Modern and performance-related remuneration
  • Attractive employment conditions

Salary.

From: Not specified
Until: Not specified

Region. Category. Discipline.

Application. Advantages.

Not found a suitable job?

FAQ. Applicants.

Apply anyway! We will then decide together whether it is worth applying. If not, we will look for another job together that fits your needs and qualifications.

For the most part already. However, there are also jobs that are not yet online. So if you don't find a job that suits you, it's still worth sending us a speculative application or simply giving us a call.

Of course we do! Even if no suitable position is advertised online, we may still have a suitable position for you.
Send us an unsolicited application or give us a call: together we will discuss everything else.

Project Consultants are permanent employees of Entourage who work for clients on temporary projects. As soon as the project is finished, there is either the possibility that the customer takes over the Project Consultant in a permanent position or the Consultant continues to work for Entourage in a new project.

It's always worth contacting us. Even if you're not looking for a new job yet. Together we can explore possibilities and opportunities and determine your current market value.

No, that is not necessary! It is sufficient if you apply for one of the positions and indicate in your message that there are other positions you are interested in. Our staff will then take care of everything else.

You should always keep us informed as to whether you have applied for jobs independently or through another recruitment agency.

After you have sent us your complete application, the responsible employee will look through your documents and then get in touch with you. Either by e-mail or by phone.
In the first phone call, you will talk about your wishes and goals and make an initial assessment of whether and which jobs from our range are suitable for you.
In a further conversation, the sales consultant responsible for the company will talk to you and check whether you are suitable for the position. In this way, we can guarantee with a high degree of probability that you will sign the contract at the end of the application process.
After that, it's straight into the application phase. We forward all the necessary information to the company and keep you informed about interview dates.
Once an interview date has been set, we will prepare you for the upcoming interview in the best possible way.

It all depends on you and your preferences and wishes.
The classic permanent position offers you a permanent job with one of our clients.
Project consulting is always limited to the corresponding project with our client. Depending on the project, it can be 6, 12 or 24 months. After completion of the project, it may be that the client extends the project. If this is not the case, we will work with you to find a follow-up project that meets your expectations.

No, our work is free of charge for you as an applicant throughout all stages of the application process.

The easiest way to apply is via our application form. Either directly to the position you want or as a speculative application.
This way, the consultant in charge knows directly which position you are applying for and can look at your documents before contacting you.
As soon as your CV and other documents such as references and certificates are available, our consultants can start working and find a suitable position for you.

The most important thing for us is an up-to-date CV. In addition, your name, telephone number and/or email address are important so that we can reach you.
Other documents such as certificates, references, cover letters and the like can also be submitted later if necessary. However, it does not hurt to include all relevant information directly in the application.

Data protection is very important to us. Precisely because we deal with people and sensitive, personal data on a daily basis, we pay very close attention to what information we pass on to third parties. 

Before we pass on a person's data, we always clarify whether the person agrees to this. 

We store our customers' data on secure servers within Germany.