LEO Pharma is experiencing worldwide success, and as part of our ambitious growth strategy we now increase collaboration with third parties in commercial manufacture. You will be a vital part of making this a successful journey – if you have experience within GMP auditing and partnership management.
Join our mission to help more people achieve healthy skin
LEO Pharma has embarked on a growth journey to become the preferred dermatology care partner in the world. This journey includes exciting global initiatives in our pursuit of new opportunities to help more people around the world living with skin diseases.
On November 11, 2015 LEO Pharma signed a Master Asset Purchase Agreement with the Japanese pharmaceutical company, Astellas Pharma Inc., to acquire Astellas’ global portfolio of dermatology products. To lead and coordinate the integration of this portfolio across the entire organization, an Integration Management Office is established, consisting of 7 people in integration management and planning, finance and communication.
Varied and highly interesting responsibility from audits to technology transfer projects
As Senior Quality Specialist you will be trusted a major responsibility as driver of highly important tasks and projects – and as inspirer and sparring partner for your less experienced colleagues. In overview your primary tasks will be to:
- evaluate new partnerships as member of a cross functional team
- plan and complete GMP audits of contract manufacturers
- establish and maintain Quality Agreements
- act as Quality representative in technology transfer projects
- create quality oversight of CMO operations including handling of deviations, changes, PQR and QMR
- maintain and develop the QMS with focus on third party compliance
- deliver quality support to our internal stakeholders
You can look forward to travelling minimum 40 days per year to meet colleagues and partners, worldwide.
+5 years pharma experience related to suppliers and/or external partners
You have a natural science M.Sc. in e.g. pharmacy, engineering, chemistry. Your previous career has provided you with +5 years’ experience within the pharmaceutical industry where you have been working with suppliers and/or external partners. If you have experience as an auditor it is a plus but experience from pharmaceutical development, manufacture or quality operations can also be the starting point.
On the personal level you have a strong quality mind-set, and you enjoy working on fast paced, strategic projects where your engagement and value adding solutions make a real difference – and you have the overview and stamina to reach your goals. As part of a truly international setup you must thrive on working together with people from different cultures. This takes an open minded and pragmatic attitude including the ability to understand that there may be more than one compliant solution to a task in hand.
Affiliates & External Suppliers Quality – your new department
You will join 15 enthusiastic colleagues located in Ballerup, Dublin and Parsippany. Our focus is to ensure second to none quality and compliance within LEO Affiliate Companies worldwide and at our third parties; including suppliers, contract manufacturers, contract laboratories and distributors. We establish quality agreements, perform audits and follow up on third party quality performance. We also participate in projects concerning new third parties and supply chain improvements. A vital part of our work is based on close collaboration with internal stakeholders across multiple departments within our supply chain. We are part of the Global Quality & EHS organization with a total of 170 employees worldwide.
We look forward to receiving your application.
