Interim Leadership: Transforming a Crucial Internal Department into an Efficient and Effective Organisation
A Case Study: How A&M Can Help Healthcare Companies Overcome Crisis Situations.
A private equity backed medical device company needed an interim vice president to fill a vacant leadership role in the organisation’s Quality and Regulatory Affairs (QRA) department, a critical function within the business to remain compliant in a highly regulated sector. The client operated with 10-plus different SAP systems that were not integrated and multiple quality management systems, one of which required 30 people to manage manual processes.
The company also faced multiple legal proceedings over its products with authorities having concerns over safety and reporting. The department had to oversee 30,000 SKUs for 8,000 products, and each SKU required regulatory documentation that needed to be updated annually.
The whole QRA department needed organisational restructuring to improve management succession and to implement a performance tracking system. The department needed better data, analysis tools and better systems to ensure timely resolution of product and safety complaints. Finally, the company needed to implement some cost cutting measures across the organisation and to hire a full-time vice president to lead the department.
How A&M Helped
The A&M interim QRA vice president stepped in to redesign the department of 400 people and initiated process improvement projects. The goal was to simplify the processes to allow the department to address complaints, remediation cases and recalls in a more efficient manner.
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