Director Of Quality – Vaccines

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About the job

Do you have a PHD or Masters degree in a scientific related field? Are you seeking a new career challenge?

Invenia Group has partnered with a high-growth start-up biotechnology organization who are on the forefront of the COVID-19 vaccine response globally. Due to rapid expansion plans, the business is now looking to hire a Director of Quality to create a brand new quality strategy for their world-class state of the art manufacturing facilities.

Role responsibilities:

As a Director of Quality, you will be responsible for setting standards for current good manufacturing practice (cGMP) quality by analyzing relevant regulatory authorities’ laws, standards, programs and activities relevant to viral vaccines. You will participate as a member of the Leadership Team and partner closely with the chief operations officer, develop operating and capital expense budgets for the Quality functions. Ensure timelines are met and costs remain within the established budget, work closely with the CTO and the Commercial function in the assessment of new opportunities and provide appropriate Quality and Regulatory input to prospective customers, including the demonstration of compliance through audit.

You will also proactively develop and sustain strong relationships with top management of the FDA including strategy design reviews prior to major capacity expansions.

What we are looking for:

The ideal candidate will have a PHD or Masters degree in a scientific related field, extensive experience in biologics (mainly gene therapy or viral vaccines), deep knowledge and practices of clinical & commercial biologics site leadership, extensive knowledge of guidelines required by FDA, EMA, and other regulatory bodies and be fluent in English, with a right to work in the USA.

This role offers a highly competitive salary, bonus and overall benefits scheme, as well as a chance to be involved in the development of cutting edge technology to treat COVID-19 globally. Please note this is a US based position which will not offer sponsorship, but will relocate individuals with an existing right to work in the US.

Sound interesting? Apply and forward your CV to find out more information regarding this opportunity.