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Global Quality Assurance Manager – GMP / GDP

Berlin based

Salary of €85 – €100k

 

If you’re a Berlin based QA leader with an outstanding background in GMP and GDP oversight and you’d like to know about a broad, challenging Berlin based role it would be great to hear from you.

 

We’re working with an EU headquartered business who have been operating for over two decades.   Historically they have been a service provider working in in a range of high expertise areas including clinical trials supplies and early access programmes.  More recently they have invested in in licensing two assets and are now commercialising these products.

 

As a result of this and as part of an ongoing investment in building an advanced, forward thinking quality function they are recruiting for a Berlin based, globally focused quality manager.

 

The overall purpose of the role is to ensure excellent standards of quality compliance on a global basis.  Specifically for manufacturing and supply chain / distribution.  One of the main priorities of the role will be to ensure that all necessary quality activities for the most recently acquired product (a niche pharma drug) are undertaken to the highest standard.

 

Headline responsibilities include

 

  • Auditing suppliers and hosting audits from customers and regulatory bodies
  • Developing the QMS which is currently paper based
  • Developing Standard Operating Procedures
  • Developing and reviewing Quality Agreements with suppliers and customers.
  • Working to proactively identify and implement areas of improvement in the quality function and aligned functional areas.
  • Ideally acting as RP and / or QP
  • While the person will be a leader in terms of expertise and strategic input they will not have formal management responsibility at point of hire.

 

The Perfect Profile

 

  • Berlin based, fluent in German and English
  • QP and RP
  • Outstanding, deep GMP and GDP skills with knowledge of other GxP disciplines (GVP, GLP GCP and GCLP)
  • Strong leadership skills and someone who is entirely happy to not manage people.
  • Experience in smaller companies where there have been a wide variety of tasks.
  • Global experience
  • Experience of products being sold and for clinical trials. 

 

An Acceptable profile.

 

  • UK, Berlin or Stockholm based with fluency in the local language and English
  • Strong GDP and GMP experience to the extent that you can work independently in these areas.
  • Desire to secure RP / QP status
  • Experience of commercial GMP QA (i.e. products being sold rather than for clinical trials)

 

For the purposes of clarity I will be unable to progress  or respond to applicants that don’t meet the minimum  requirements for this role.

 

For the right candidate the company can offer a genuinely exciting and rewarding role.  You’d be joining an existing global team of outstanding quality professionals at a exciting, growth focused period in the company’s development.  Your contributions would be visible, valued and acted on and there would be short, medium and long term opportunities for skill and career development.

 

If you’d like to know more it would be great to hear from you.  You can express an interest by;

 

Applying to this role (ideally!)

Contacting me by email at Andrew.wise@bluepelican.com

Or sending me a connection request / message via LinkedIn; you’ll find me at https://www.linkedin.com/in/andypjwise/

To learn more about this role, please apply or contact Andrew directly on andrew.wise@bluepelican.com

How to apply

If this position is of interest please send us your CV here, or you can call Andrew Wise direct on to discuss this and other vacancies that may suit.

Andrew Wise

Email: andrew.wise@bluepelican.com