Global Quality Manager

Inceptua is a global, dynamic and future-oriented service provider for the pharma-

ceutical industry. Inceptua has global operations within medicines access and unli-

censed medicines, clinical trial supply chain and manufacturing as well as commer-

cial products and services. 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 perfor-

mance 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 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 docu-

ment 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 clini-

cal 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:

• Preferably have the experience and background to act or support as a QP/RP

• Maintaining and improving the Global Quality Management System

• Initiate and support process optimization initiatives and revise SOPs

• Act as internal and external expert for GMP and GDP related topics

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

sites, warehouses/depots and transporters according to GMP/GDP require-

ments in EU but also Worldwide

• Qualify and re-qualify external service providers, customers and suppliers for

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

• 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

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Your profile:

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

• You have at least 5 years working experiences in QA GMP on a global level,

within the pharmaceutical industry

• You have preferably previous experience of the QP/RP role

• Knowledge from Bio-tech products

• You have extensive knowledge in and understanding of GMP, GDP and asso-

ciated 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

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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