Wanted – Head of Quality & Regulatory Affairs for a Bio-Chromatography Products & Services company


wallder consulting

An outstanding opportunity has arisen for the right person: a growing company, in a growing market with a fairly unique range of products and services sought after by big pharma.

The role is based in Cambridge, UK although company has locations in North America and elsewhere in the UK. Ideally candidates should be based within reasonable reach of Cambridge or be prepared to relocate.

We seek a scientist with at least 5 years’ experience in the biotechnology, life sciences, medical or diagnostics sectors and significant knowledge and experience of Regulatory Affairs, Quality Management and working with the regulatory bodies. The role is a 50/50 split between QA and RA in terms of time and requirements and candidates must be equally well versed in both QA and RA.

Reporting directly to the CEO, the primary purpose of the role is to: ensure that the company is compliant with all relevant quality standards and regulations; provide the company with current quality and regulatory information and advice; and developing a quality environment and good Quality Management Practice.

From an RA standpoint the individual needs to know and understand the product applications and applicable GMP regulations so as to be able to provide the company and its clients with appropriate regulatory support. While certain parts of the company are actively developing pharmaceutical products, this role  is not about front line registration but more orientated towards providing information and advice to support the use of the company’s bio-separation products and technology as components of regulated processes and products. This will include responsibility for the generation of product safety data.

For further information contact : David Wallder

Mobile: +44 (0)7887 540035 Office: +44 (0) 1727 822855

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