Culture Development – A Focus on Quality

Case Study

Performance circle
An international pharmaceutical organisation identified that something different needed to occur for them to build a stronger level of compliance and focus from their staff on the ‘quality’ of their research, operations and development. They knew a holistic program was needed to create lasting change in the culture of the organisation around quality.

Challenge

With a diverse functional organisation, each with part ownership, if not complete ownership of the quality lifecycle, the organisation faced challenges in establishing and coordinating a culture improvement program. Curve Group were engaged to help work with functional areas, the executive leadership, and the project team to help respond to short-term remediation needs as a result of a key regulator’s quality warning letter.

Our Approach

Curve Group completed a number of diverse activities all designed to help drive the quality culture of the organisation. This included; a review of the internal Quality Function in Australia, design and facilitation of a strategic off-site for the executive leadership team to focus on quality and compliance, development of a bespoke leadership program for quality,  support to the project manager to setup a program of work to respond to the regulators warning letter, as well as a long term sustainable change program for quality.

Outcome

The quality function in this organisation identified the key changes to the way they worked and operated and took action to transform. Suitable response activities were recognised by the regulatory auditor relating to the original warning letter and thus remediation activities were accepted. Furthermore, a longer term agenda of work was established and agreed to by key stakeholders to improve the compliance and quality focus at the organisation.

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