Associate Director - Global Quality Assurance

Posted 3 September by Blue Pelican
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If you’re a quality compliance professional with a strong background in auditing who wants to take on a more business-facing role, without moving away from auditing altogether it’d be great to speak with you about a role I’m handling.

My client is a well established and highly respected leader in their field. As a research-based pharma business, they have a focus on both well established and novel therapeutics and are recognised as a great place to work. They have a highly engaged and supported employee base and absolutely don’t confirm the model f a hard-edged corporate business.

The main purpose of the role is to act as the subject matter expert within the business across all GxP disciplines with a focus on GCP, GMP, GVP and GDP. You’d also be heavily involved in other areas of compliance including medical codes of practise, regulatory compliance. In essence we’re looking for someone who can take a holistic view of the compliance framework and ensure that not only is it as strong and robust as possible but also ensure that the business is aware of and bought into the quality culture.

Examples of responsibilities include:

  • Acting as an ambassador on behalf of the quality function in all matters relating to quality compliance.
  • Acting as the subject matter expert and thought leader within the business and being recognised as the go to person for the area.
  • Setting out and reviewing key indicators of performance and addressing shortfalls where necessary.
  • Process management across a span of compliance activities.
  • Leading on defined quality training and performance programmes.

There is also an important hands-on aspect to the role in respect of actually conducting audits, authoring investigation reports and liaising with relevant authorities.

While the right candidate could come from a variety of backgrounds the following are absolutely key, non-negotiable requirements for the role.

A strong background in pharmaceutical / medical GxP compliance including expertise in a combination of GMP, GCP and / or GVP QA.

A demonstrable and credible background in auditing.

An ability to think beyond the operational tasks at hand and consider the broader impact of compliance on the business.

This would be a great opportunity for a strong, business-focused GxP auditor to transition into a more corporate, business-facing role and progress their career.  Our client genuinely has a great reputation as an employer and place to work and as well as a great remuneration package there would be ongoing training and career development opportunities.

If you’d like to know more it’d be great to hear from you!

Reference: 40819853

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