We are recruiting a Head of Quality Assurance

Fresenius Kabi is a global health care company that specializes in lifesaving medicines and medical technologies for infusion, transfusion and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. We are part of Fresenius SE, a health care group with more than 100 years of experience in pharmaceuticals, medical devices and life sciences. Our employees – more than 35,000 worldwide – develop and deliver injectable pharmaceuticals and infusion systems; blood collection, transfusion and cell technologies; and essential nutrients for parenteral nutrition.

Whether you work for us, buy from us, partner with us, or invest in us, you will come to know that caring is at the core of everything we do. Our purpose is to put lifesaving medicines and technologies in the hands of people who care for patients, and to find answers to the challenges they face every day.

The Uppsala Innovation & Development Center (I&DC) consists of approx. 40 people who are responsible for pharmaceutical development of parenteral nutrition products. This comprises design of new formulations, development and validation of analytical methods and registration stability studies. The Head of QA is a key role to ensure the further development and maintenance of the QMS of the I&D Center and for development projects. As Head of Quality Assurance you report to the Quality Director of the Department “ I&D Centers & Quality Systems” , within the global Quality Management Organization.

 

Job description:

Manage a small team of (Senior) QA Specialists and Q-consultants
Represent QA within the management teams of I&DC Sweden and in QM I&D Centers
Establish, maintain and continuously improve the Quality System of the I&D Center in compliance with global quality standards
Quality Management System gap assessments, audit preparation, definition and follow-up of corrective and preventive actions to improve the QMS
Maintain and support quality related processes within I&D Center incl. preparation of management review, metrics meetings, collection/review/analysis of KPIs
Quality oversight incl. equipment qualification, method validation, change control, deviations, OOS handling, CAPAs, audits etc.
Coordination, administration and performance of quality and GxP trainings
Review and approval of Q-related documents
 

Job requirements:

MS (or PhD) in a relevant scientific discipline
At least 8 years’ experience in pharmaceutical or device quality assurance (quality systems, audit, qualification, CAPA management, e.g. Trackwise®)
Broad experience in supervision of Quality Management/Quality Assurance System
Excellent knowledge of ISO9001:2015 and regulations in pharmaceutical and medical device industry (21CFR Part 4, 21 CFR Part 820, 21 CFR Part 210/211, 21 CFR Part 11, EudraLex Volume 4)
Experience in pharmaceutical or device product development; experience in combination product development is an advantage
Very good ability of oral and written communication in English
Good leadership and strong communication skills, at least 5 years in a management position
Ability to work independently and solution oriented
Good networking abilities, working in multidisciplinary international teams
Experience with authority inspections (e.g. US FDA) desirable
 

What we offer:

Very diversified responsibilities
A highly interesting job
Freedom to act on your own initiative
 

This is a very interesting opportunity for a diligent, self-motivated and results oriented individual with strong personal presence and excellent interpersonal skills. If you are interested in this position and your profile matches the above requirements we are looking forward to receiving your application.

The position is a temporary employment that can turn in to a permanent employment if both parts agree after 6 months. The position is placed in Uppsala.

If you want to know more about the position you are welcome to contact Martin Schimmel, +49 6172-686 6304. Union representatives are Frank Glackin for Unionen, 018-644 773 and Teresia Karlsson for SACO, 018-644 304.

We look forward to your application! Selection and interviews will be ongoing during the whole application period, so please register your application as soon as possible.
We do not accept applications by e-mail or post.