Performance Excellence Partners collaborates with small and mid-sized pharma and biotech firms to develop tailored solutions focused on strengthening compliance, boosting operational performance, and enhancing organizational capabilities.From pre-clinical development through commercialization, the pathway to success is consistent with complexities and challenges. Having a trusted partner along the way to help navigate the journey is invaluable.

- Developed Corporate Quality Strategy focused on compliance, performance and capabilities.- Established Corporate Standards as a foundation and governance for Corporate policies.- Directed a wide variety of activities that facilitate a 3-way alignment between Quality Systems, SOPs and Corporate Standards, ensuring compliance with global health authority regulations.- Developed a comprehensive Quality Culture Program to boost overall Quality maturity.- Provided training, coaching and mentoring to create highly capable teams who are inspection-ready at all times.

- Directed the development and implementation of the Global Quality Strategy, with a focus on Compliance, Performance Excellence and Enhanced Capabilities.- Defined the execution workstreams, target state, milestones, deliverables, and interdependences, which governed the critical path.- Led implementation workstreams, ensuring realization of strategic, operational and tactical improvements.- Collaboration with cross-functional executive leaders to provide expertise impacting critical Technical Operations decisions.- Negotiated and defined Transactional Service Agreements and Quality Technical Agreements for mergers, acquisitions and divestitures.

- Established and directed the Corporate Quality Project Portfolio Management Office (PMO), responsible for oversight of continuous improvement and remediation projects within Technical Operations.- Continuous improvement projects focused on developing new and optimizing existing processes to improve communications, strengthen handoffs, shorten cycle times, and clarify procedures and work instructions to reduce deviations.- Orchestrated the successful implementation of offshoring product testing initiatives, ensuring seamless harmonization of transfer activities and driving down the total cost of quality.- Directed the Offshoring Stability Testing Program, achieving a substantial improvement to forecast accuracy, resulting in a 20% reduction in under-absorption at the offshore centers.- Established a strategic logistics partnership to enhance customs clearance efficiency, minimize risk of temperature excursions and optimize cost-effectiveness with a ~25% reduction in offshore logistics spend.- Led the annual recalibration and target-setting process for Key Performance Indicators (KPIs) across critical Quality compliance, performance and cycle time activities.

- Appointed to Quality Risk Management Champion to identify quality, manufacturing and third party operations-related risks potentially impacting patient safety, recalls, drug shortages, business financials and public relations.- Developed a formal QRM submission process to categorize, analyze, and evaluate potential risks against a defined set of criteria, including the vetting of assumptions to minimize subjectivity.- Risk monitoring and design control was prioritized based on a benefit-cost analysis to balance effort with significance of the risk.

Osman Inc. is a management consulting firm supporting Technical Operations in Pharma, Biotech, Medical Device and Consumer Health to strengthen cGMP compliance, improve performance, and enhance overall capabilities.