Pharmaceutical companies are headed in a new direction in the non-blockbuster era. As a result, pharma leaders are in a unique position. This New World has resulted in widely dispersed and disparate operations. Successful leaders will be those who harness the diversity and complexity, versus those who fight to centralize and control and would benefit from a light touch approach.
The light touch approach establishes a collaborative steering committee that creates and self-manages the quality process. When Caremark International spun out of Baxter, I led the global quality, regulatory and operations steering committee to govern business units in in Europe, Canada, Puerto Rico and Asia. Key elements of the structure were:
- A global operations, quality and regulatory steering committee
- CEO direction for the few non-negotiable items
- Collaborative agreement on the next level of light touch policies
- Understanding of the areas where independence was okay
- Meaningful, obtainable metrics
- Regular meetings or touch points to keep the process moving forward
The benefits of this approach were that it included key stakeholders, avoided the heavy hand and promoted collaboration and sharing of best practices (and best people). A side benefit was that this approach created peer pressure for the business unit’s quality and regulatory assurance functions to be accountable to each other.
The Life Science practice for West Monroe Partners offers a broad platform to assist clients from both a technical and management consulting perspective. We can assist with:
- Preparing topics and direction for key stakeholder meetings
- Developing a solid agenda and advance communication
- Supporting you and/or facilitating key meetings
- Converting meeting decisions, notes and action items into a clear/concise management process
- Constructing appropriate communication of the outcome upward to C-level leaders and horizontally to your extended stakeholders
How is your organization managing New World quality and oversight?