Head of Quality Assurance I&D to Fresenius Kabi in Uppsala

Job description
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 of 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 and encompasses leadership as well as operative and strategic tasks. 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.

Responsibilities
In this role you will be responsible for:


Managing a small team of (Senior) QA Specialists and Q-consultants
Representing QA within the management teams of I&DC Sweden and in QM I&D Centers
Establishing, maintaining and continuously improving 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
Maintaining and supporting quality related processes within I&D Center incl. preparation of management review, metrics meetings, collection/review/analysis of KPIs
Implementation of the data governance strategy and ensuring data compliance oversight
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


Working hours
The Position is a permanent full-time employment, probationary period applies. The Position will be based at Fresenius Kabi’s site in Uppsala Business Park at Rapsgatan 7.

Qualifications
The ideal candidate for this posision has the following qualifications:


MS (or PhD) in a relevant scientific discipline
Several years of experience in pharmaceutical or device quality assurance (quality systems, audit, qualification, CAPA management, e.g. Trackwise®)
Experience from a management position within the Life Science industry
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 analytical & formulation development or combination product development is an advantage
Experience with authority inspections (e.g. US FDA) is desirable
Very good ability of oral and written communication in English and Swedish

As a person, you are self-motivated, results oriented and face challenges with a strong drive.  You have the willingness to work operationally when needed and collaborate internally across the organization in multidisciplinary teams and you have good networking abilities. You enjoy motivating your employees and strive to develop the team in order to reach set goals and targets together. You have great communication skills and can explain strategies and goals in a clear way.

This is a great opportunity to have diversified responsibilities, a highly interesting job and the freedom to act on your own initiative.

Application

Deadline for application is  2021-05-18. Selection is continuous and the position may be filled before the last day of application, therefore – please apply as soon as possible. Please write your application in English.

Fresenius Kabi is working together with Randstad Life Sciences in this recruitment process. For information, please contact recruitment consultant Hedvig Strandberg, Hedvig.strandberg@randstad.com. 

Because of GDPR we are not allowed to handle applications by e-mail and applications sent through e-mail can therefore not be processed.  For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity. 

About the company
Fresenius Kabi is a global healthcare company which specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. With its corporate philosophy of "caring for life", the company is committed to putting essential medicines and technologies in the hands of people who help patients and finding the best answers to the challenges they face.

Fresenius Kabi’s product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies, clinical nutrition products and the medical devices for administering these products. Within transfusion technologies, our client offers products for whole blood and blood components collection and processing as well as for transfusion medicine and cell therapies.

Fresenius Kabi AG is a wholly owned subsidiary of Fresenius SE & Co. KGaA. Fresenius is a global healthcare group offering high-quality products and services for dialysis, hospitals, and outpatient treatment. With over 270,000 people in more than 100 countries around the globe, and annual sales of over € 34 billion, Fresenius is one of the world’s leading healthcare companies. Fresenius Kabi employs 37,800 people worldwide. In 2019 sales exceeded € 6 billion.