QA Manufacturing Director, QP - Northern Europe (Relocation)

QA Manufacturing Director & QP - Northern Europe (Relocation)
Are Would you like to build and lead a QA Manufacturing team at a major biosimilar manufacturing site in Northern Europe? Are you an experienced QP within the pharma/biotech space?

Then this might be the role for you!

A great client of ours is looking for an experienced QP to head up a QA Manufacturing team supporting Drug Substance Manufacturing and Drug Product Manufacturing.
They are targeting relocators from anywhere in the EU, so this could be an excellent opportunity for somebody looking to progress their career in Northern Europe!

The Company
The company is fairly young, but already well established CDMO on a mission to improve patient lives by expanding access to affordable biologic medicine in a variety of therapeutic areas, two major ones being Immunology and Oncology. They are specialized in biosimilar technology and have state of the art R&D and manufacturing facilities in-house.

They're expecting further growth, currently undergoing a major expansion at their manufacturing facility and seeking motivated candidates looking to grow alongside them. As such they provide great internal progression opportunities and we've seen many of our candidates continue developing their career with them.

The Role
The new QA Director will be responsible for:
- Building and leading a QA Manufacturing team
- Acting as Qualified Person and providing QP expertise and support to other functions
- Performing batch certification and release of commercial and clinical material
- Support and approve Change Control records related to area of responsibility
- Participate in preparation of Audits and Inspections
- Review and approval of master batch records and product specifications
- Participate in management of Customer Complaints, investigations and associated CAPAs
- Overall responsibility for product recalls
- Support technology transfer projects, risk assessments, and process and cleaning validation
- Draft, review and approval of Quality Operations SOPs and of documents from areas of responsibility

Qualifications
They're looking for a candidate with extensive experience in the quality assurance of pharmaceuticals/biologics and experience as a QP, who is open to relocate.

Fecha de publicación: 28/09/2022