Head of Regulatory Analysis

2 weeks ago

London, Greater London, United Kingdom Impel Talent Full time

Impel has been retained to manage an exciting search for a Director to Senior Director level Qualified Person for one of our clients, a prominent Biologics company with a global footprint.


The Head of QP will be a key position within the Quality and Manufacturing organisation, acting as a subject matter expert for GMP and managing a team of QP professionals to prioritise varied complex projects.

This position will be reporting to the VP of Quality and is seen as one of the most important functions in the 300+ fte Quality organisation at this 1000+ fte site.


A broad understanding of Quality (QA/QC/QMS) and Manufacturing would add value to how you manage the strategic and operational goals and clearly communicate your decisions to internal and external stakeholders.

This is a role where being present and agile is extremely important.

Provide key insight and help define short- and long-term operational and strategic objectives for the Quality, Manufacturing and QP operations

Managing 6 QP Delegates with the core function of batch disposition to guarantee the quality and safety of the products

Assisting in regulatory and compliance activities, ensuring adherence to industry regulations and standards whilst being able to think "outside of the box"

Providing support during regulatory inspections and contributing to the preparation for these business critical events

As part of the senior leadership team of the Quality organisation, you will have to make informed QP decisions that drive continuous improvement and align with the concept of 'fit for purpose' that will impact processes and analytical methods on a local and potentially global scale


Maintaining a strong presence on the shop floor whilst actively engaging with operational teams to enforce a culture of Quality and GMP excellence.

You will develop, mentor and train across the Quality and Manufacturing operations whilst leading by example to foster a GMP and Personal Development culture that impacts quality and compliance

10+ years' experience as a QP (Qualified Person) with a minimum of an MSc in Industrial Pharmaceutical Science or a related degree that is recognised by Regulatory Authorities to permit QP status as per Article 49 of Directive 2001/83/EC

~ Proficient in one or more Technical Operational area, such as QA, QC or Manufacturing

~ Knowledge of scientific principles for the manufacture of biological molecules

~ In depth understanding of analytical techniques used for the analysis of manufactured biological products.

Strong decision-making skills and a 'can do' attitude with the ability to work in a fast-paced, agile and matrix environment

You are someone who can prioritise multiple tasks, projects and work to stringent deadlines whilst being flexible to meet changing business needs

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