Quality Specialist to External Manufacturing

Do you have a strong QA profile, a global mind-set and a strong desire to continuous improvements? Then you may be our new colleague in External Manufacturing Quality (ExMan Q).

As Marketing Authorisations Holder for a wide portfolio of products, a key operational challenge for LEO Pharma is to ensure GXP and Regulatory compliance in an expanding and increasingly complex network of external manufacturing partners. This is the responsibility of ExMan Q.

The QP’s from the Contract Manufacturing Organisations (CMOs) are responsible for release of products as well as for the documentation in this connection. As Quality Specialist you are responsible for Quality Oversight in relation to specific CMOs. Furthermore, you are expected to utilize your professional competences in the development and maintenance of the LEO Quality Management System towards external manufacturing together with your colleagues.

QA approach based on Quality Oversight and Quality Risk Management

It is our defined goal to succeed in providing continuous oversight of the QA related processes. This requires a waterproof quality system that enables us to react proactively to incidents that could jeopardize our quality. In this connection you will have responsibilities within:

  • Establishment of solid, robust and transparent Quality Agreements as framework for the quality related partnership with the CMOs
  • Continuous QA efforts based on the LEO Quality Management System and Quality Risk Management
  • Quality relations with CMOs including regularly meetings
  • Periodic quality reviews as audits and APQR’s

Furthermore, you will be responsible for establishment and maintenance of standards in relation to selected elements of the Quality Management System.

By joining the team you will have an outstanding opportunity to use and develop your professional and personal competences and to contribute to business critical partnerships. You must do this across professional and cultural borders while involving multiple stakeholders internally and externally. Related to this, you can look forward to travel approx. 20 days per year to audit and meet partners and colleagues.

Master of Science with strong QA skills

You hold a University degree within Pharmacy, Engineering or a similar discipline and you have at least 5 years’ relevant experience from the pharmaceutical industry. If you have been working in a similar position, as a QP and/or as an auditor it will be considered an advantage.

You are recognised for your ability to deliver excellent QA results without compromising your personal integrity and long term perspective. You can create quality awareness, continuous improvements and team work among your stakeholders utilizing the combination of your excellent professional skills, your problem solving skills and your can-do attitude. 

External Manufacturing Quality – your new work place

In ExMan Q you will join a smaller, international group of skilled and dedicated QA specialists. Your colleagues are having the same role as you meaning you will have great opportunities to share knowledge and contribute to creating best-in-class processes and tools.

We work close together with our Quality colleagues in the External & Support Quality area and our key stakeholders from External Manufacturing. Our aspirations are to be known as open-minded and ambitious while never forgetting that people who have fun create the best results.

We look forward to receiving your application.

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About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions.
Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions.
LEO Pharma is headquartered in Denmark and employs around 4,800 people worldwide.
For more information, visit www.leo-pharma.com.
Application deadline: 18 Aug 2017

Location: Ballerup, Greater Copenhagen, DK

Job type: Permanent

Working hours: Full-time

Contacts: Lene Due Svensson
Mobile: +45 9393 2710

Lilli Møller Andersen
Mobile: +45 31168337