Managed quality and compliance services for a leading innovative medicines company
Situation
A top 10 global pharmaceutical company with operations in over 150 countries sought to standardize compliance and validation delivery across its portfolios, optimizing delivery costs through continuous improvement and innovation.
Solution
- Conducted 50+ workshops across key stakeholders of nine functions and leaders to design and fine tune managed service model, governance structure, demand and capacity management, KPIs and SLAs.
- Rationalized all the existing validation vendors and became the single vendor for their compliance and validation needs.
- Conceptualized, developed and launched adjutant value add services to the current activities and synthesized wide array of information and created knowledge artifacts.
- Brought in innovation in the form of BOT, Chatbot and Uberization of profiles.
Challenges
The organization's siloed validation structure and heterogeneous processes have led to inconsistent levels of delivery quality, inefficient ad-hoc demand management, elevated operating costs, and increased audit scrutiny due to a lack of confidence in the current validation model.
Key Outcomes
- 18+ vendors rationalized globally to become the single vendor partner
- CHF 1.5 million / year savings plan through introduction of value-add services
- With 110+ resources across eight countries advised
- 1500+ projects on compliance and validation requirements