EMQA Manager - Steriles

Job title : EMQA Manager - Steriles
Location : Lower Austria
Job type : Permanent
Contact name : Aisling Hamill
Contact email : aisling.hamill@seclifesciences.com

A leading global pharmaceutical company are looking for an External Manufacturing Quality Assurance Manager to join their team.

Our client is a world leader in the field of ophthalmic pharmaceuticals and medical devices. They are looking for a Quality Assurance Manager to support them in managing their third-party suppliers. The successful candidate will be working 100% remotely with an international team.


What you will be doing:

You will be responsible for managing, integrating and sustaining relationship with external manufacturers and ensuring supplier quality.
You will participate in supplier selection and qualification, including due diligence audits and quality assurance agreements.
You will participate in supplier maintenance, including managing supplier audits, Quality Change controls and overseeing CAPAs.
You will act as an internal process expert, supporting EMQA associates and EMOs during projects.
You will report triggering events and issues to management.


A little about you:

You have previous experience working with steriles, finished dosage drug products and in external manufacture management, ideally with more than one CMO.
You have previous experience working in operation QA (GMP, audits, CAPA, change controls, etc.)
You possess a Master of Science/PHD in a chemistry/health-related discipline.
You have knowledge of executing quality systems related to medical devices and pharmaceuticals.
You have a good grasp of European Union GMP, EEC Directives/MDD, ISO 13485 and ISO 9001.
You are fluent in English.
You are willing to travel 30-50% of the time.


What's in it for you?

A competitive salary and benefits package including a generous bonus, private healthcare and pension programme.
The chance to work fully remotely for a global industry leader.

If you would be interested in a confidential discussion about this and other roles please send an email to aisling.hamill@seclifesciences.com.