Global Quality Manager, Clinical

Global Quality Manager, Clinical

07 Aug 2020

Global Quality Manager, Clinical

Inceptua Group is a pharma company and service partner. We bring medicines to patients through


clinical trial distribution services, pre-approval and unlicensed medicines access, and


commercialization of specialty and rare disease products



We recognize that investing in talented people creates value for our customers, our employees, our


suppliers and the communities in which we live and work. Our success is based on the motivation,


dedication and performance of our people. We strive to go the extra mile and achieve excellence in all


our services.



We are hiring for the position of Global Quality Manager to be based in our offices in Berlin, in


Windsor or in Stockholm, for immediate start.



You will become part of our global Quality Team and you will be working closely with different internal


functions to support Inceptua’s manufacturing, storage and distribution activities for medicinal


products mainly in EU but also world-wide.


As an experienced professional, you will independently plan, execute and document all quality-related


activities with focus on efficiency and the required level of detail to ensure the high-quality standards


for the world-wide distribution of clinical trial material, commercial products and unlicensed medicines


in early access programs.


With your extensive knowledge on GMP and GDP requirements you will help to maintain Inceptua’s


GxP activities compliant as well as performing final release of products. You will be able to contribute


with innovative ideas to build and improve internal structures in the changing environment of our


growing organization.



Responsibilities include, but are not limited to:

  • Maintaining and improving the Global Quality Management System

  • Initiate and support process optimization initiatives and revise SOPs

  • Act as internal and external expert for Packaging and Labelling of and manufacturing for Clinical

Trials


  • Prepare, conduct and follow-up physical audits of external manufacturing sites,

warehouses/depots and transporters according to GMP/GDP requirements in EU but also


Worldwide

  • Qualify and re-qualify external service providers, customers and suppliers for GMP/GDP related

and associated services

  • Prepare and conduct internal audits (self-inspections) to monitor and ensure compliance with

GMP/GDP and internal quality standards

  • Represent the company in Authority inspections and client audits

  • Conduct daily tasks related to the processes described in the QMS

  • Perform internal cross-functional trainings

  • Develop and review quality agreements

  • Execute the responsibilities according to lawful and ethical standards

  • Provide suggestions for improvement for the QA department, and work on cross-functional

company initiatives across the Inceptua Group


  • Support the creation of quotations for clinical GMP activities to be undertaken on behalf of our

clients by vendors based in multiple countries

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  • Being the client liaison for requests for support with packaging, labelling and blinding

requirements

  • Set up project plans for clinical manufacturing activities undertaken for our Sponsors’ clinical

trials


Your profile:

  • You hold a University degree in natural sciences (Biol., Pharm.)

  • You have a minimum of 5 years’ experience in Packaging and Labelling for Clinical Trials and a

good knowledge from blinded and double-blinded tests for Clinical Trials, on a global level


within the pharmaceutical industry. An additional experience in GMP is of advantage.

  • You have a good knowledge from Bio-tech products

  • You have extensive knowledge in and understanding of GMP, GDP and associated regulations

  • You are willing to travel internationally

  • You are business fluent in English

  • You have a pragmatic Quality mind-set

  • You have an overall company view and mindset

  • You are a proactive team player

  • Ideally our candidate will have experience of Direct to Site, Just in Time and Direct to Patient

activities in the Clinical Trial space



This position is full-time, and we offer a competitive salary.



Our company is home to employees from various backgrounds that speak a range of languages.


If you have a forward-thinking attitude and are ready to go the extra mile with us, we look forward to


receiving your application.


Please send your application in English, including a covering letter, to


recruitment@inceptua.com. Attachments must be in PDF format.


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