QA Professional with leadership potential

Quality
Denmark - Bagsværd
Are you wondering how to increase your market value and expand your career opportunities? Adding Quality Assurance (QA) to your CV will open the door to a broad range of positions within the Pharmaceutical industry. If, for example, you are dreaming of a leadership position in Novo Nordisk, this job in Chemistry, Manufacturing and Control Development (CMC) QA will be a useful step on the way, since a profound and documented quality mind-set is an essential attribute for a Novo Nordisk leader.

CMC is a part of the Research & Development organisation, developing molecules into commercial products for non-clinical and clinical trials. We develop and formulate all new protein and peptide processes coming out of our research units in our pilot plants, ensuring that we bring best-in-class treatments to the market.

About the department
Our QA mission is to assure that each and every Active Pharmaceutical Ingredient (API) activity in our development projects live up to the cGMP requirements for the safety of our patients.

We are 43 colleagues in three teams. You will be part of a small dedicated team of 7, solely responsible for the quality, status assignment, and implementation of all new GMP materials in control in CMC Development. You will be responsible for Contract Manufacture Organisation (CMO) produced GMP materials as well as standard off the shelf materials.

The position
As a QA Professional, you will be responsible for delivering best-in-class quality of materials and excipients used in GMP production of API and drug product for clinical studies. You will collaborate with stakeholders in different departments with many different areas of expertise such as scientists in the pilot production, sourcing professionals and of course your QA colleagues.

In CMC Supply we approve suppliers of GMP materials based on a risk based approach. In your daily work you will be challenging and approving supply chain evaluations, specifications, suitability evaluations and other supporting documents. You will be reviewing work orders for CMO produced materials and evaluating or approving Non-Conformities (NC) and Change Requests (CR) related to production at a CMO. You will evaluate the need for audits with external suppliers and participate in the audits. You will also evaluate the requirement for and negotiate quality agreements with external suppliers.

In our team, we are continuously improving the quality of the materials in control in CMC Supply; we are constantly optimising our methods and processes as part of a LEAN culture. We make a difference in the lives of people participating in clinical trials in Novo Nordisk, by ensuring that the products that are received are safe, of the highest quality, and produced in compliance with legislation.

Qualifications
You hold a Master’s degree in Pharmacy, Chemical Engineering or possess equivalent qualifications besides a strong quality mind-set. You have experience working in a GMP environment and preferably with handling GMP materials and CMO productions.

You are ambitious and see this job as an opportunity to develop your communication and negotiation skills and are determined on creating world-class results ensuring the highest quality of the materials in control.

You have experience working in a LEAN environment and enjoy working in a team where we constantly improve our methods and processes.

You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders. You have good interpersonal skills and you keep your spirits high even under pressure.

As we operate both in a national and an international environment, you must speak and write Danish and English fluently.

For more information please see link: http://www.novonordisk.com/cmc-careers.

Working at Novo Nordisk
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

Contact
For further information, please contact Rebekka Dam-Tuxen at +45 3079 1355 or Uffe Larsen at +45 3075 6114.

Deadline
25 January 2017.