Benchmarking BioPharma Quality and CAPA Processes: Quality Staffing and Outsourcing Trends

STUDY OVERVIEW

Biopharmaceutical companies invest heavily to ensure their products meet Quality standards.

But as costs rise, Quality leaders face a constant struggle to balance quality and safety with costs and risk. Ironically, Quality staff play a big role in both - they are a cost driver and a quality enforcer. Maintaining the appropriate mix of Quality staff is therefore important to both safety and cost.

Research and consulting leader Best Practices, LLC undertook a new study that reviews current Quality staffing levels for biopharmaceutical companies, including total Quality staff, Quality staff per $100 million in revenue and Quality staff as a percent of total staff. The study also has insights on the advantages and risks of outsourcing Quality roles.

Quality leaders can use this research to compare their Quality staffing levels with their peers.

This study presents two segments on some questions: All Participants and Large Companies

KEY TOPICS

• Quality Staff Levels
• Outsourcing Quality
• Best Practices for a Robust Quality Function

• Total number of FTEs in Quality function
• Quality FTEs per $100 million in revenues
• Quality FTEs as a percentage of total FTEs
• Percentage of Quality activities does in-house versus outsourced
• Percentage of Quality in-house activities done in established markets versus low wage markets

• Outsourcing Quality: In order to build successful outsourcing capabilities, companies must understand how to manage risks associated with outsourcing processes. A majority of the benchmark class (>85%) manages quality activities in-house for the 7 activities that were evaluated in the study.
  

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