Senior Quality Assurance Manager

​Senior Quality Assurance Manager

We are exclusively partnered with an exciting CDMO that are investing heavily to expand their offering across drug development, with a real focus on biologics and wider biopharmaceuticals.

As part of this expansion, this position is a brand new senior Quality function that must be willing and able to take on all aspects of quality assurance responsibilities in relation to biologics drug development.

Taking ownership of developing and implementing a quality management system, the successful candidate will take technical responsibility for key regulations specific to GMP, biologics and CMC technical transfer documentation.

Outstanding stakeholder management skills are essential given the need to liaise cross functionally internally, as well as directly with clients.

For further details, please contact Mark Bux-Ryan.

Key experience:

• Established Quality Assurance experience within the pharmaceutical industry - minimum 5 years within biopharmaceuticals

• Technical knowledge with 21 CFR Parts 210, 211, 600 and 610, is essential

• Strong customer and client management capability

• The ability to work in a combined senior capacity, whilst remaining hands on

• Experience and willingness to develop QA strategy including planning building resource and delivery potential

Quality, assurance, QA, biologics, biopharmaceutical, CFR, 21, 210, 211, 600, 610, GMP, manufacturing, development, CMC, technical, transfer, management, system, CAPA, deviation, change, control