Maximizing Clinical Excellence: The Role of the Vice President in Steering Quality and Development Integration in Pharma

Introduction

Introduction:

In the pursuit of pioneering advancements in clinical development and ensuring rigorous adherence to Good Clinical Practices (GCP), the role of the Vice President, Quality Center of Excellence becomes pivotal. Process management within this context refers to the meticulous governance of certified procedures and quality standards that span the clinical development phases I-IV and regions, incorporating the realms of Development Japan and Development China. Central to this role is the unwavering commitment to steward the Enterprise Quality Management System, harmonizing the excellence of quality deliverables with the strategic imperatives of Global Product Development (GPD) and its ancillary entities.

To encapsulate the essence of process management in the day-to-day work of this role, one must consider it as the bedrock of operational integrity and the blueprint for clinical excellence. It involves diligent oversight of GCP Quality Standards and Quality Management System (QMS) processes, ensuring they stand robust against the scrutiny of global compliance and regulatory mandates, such as the ICH and GDPR. The vigilant management of quality events, the establishment of GCP risk management, and the ensurance of readiness for audits and inspections embody the daily operational tenets that foster a culture of quality and continuous improvement within the organization.

Process management for the Head, Quality Center of Excellence is unique and multifaceted—it extends beyond the confines of clinical process excellence to include leadership in business development integration, spearheading regulatory resource strategies, and embedding best practices across the business spectrum. The role advocates for quality across all facets of GPD, championing a quality-minded ethos and driving innovations that fortify the confluence of quality, regulatory excellence, and business agility. Thus, the essence of process management in this setting is not just about maintaining consistency; it transcends to being a strategic enabler of sustainable growth, partnership, and transformation along the entire clinical development continuum.

KanBo: When, Why and Where to deploy as a Process Management tool

What is KanBo?

KanBo is a process management tool that integrates with Microsoft ecosystems, designed to streamline work coordination, task management, and team collaboration. It offers comprehensive features like real-time work visualization, customizable workflows, data management, and deep integrations with existing on-premises and cloud environments.

Why use KanBo?

KanBo is utilized to enhance productivity, improve task visibility, foster seamless communication, and efficiently manage projects. Its ability to customize workflows and manage data securely—whether on-premises or in the cloud—makes it an ideal tool for organizations seeking to optimize their processes and abide by compliance standards.

When to use KanBo?

KanBo is suitable for use in situations requiring meticulous process management, such as planning complex projects, tracking tasks and their progress, scheduling, resource management, and monitoring quality assurance activities. It's particularly handy for cross-functional initiatives involving quality and development integration.

Where is KanBo used?

KanBo can be used in any business environment requiring process management, from corporate headquarters to remote and distributed teams. As it is compatible with the Microsoft suite, it can be easily implemented within environments that leverage SharePoint, Teams, Office 365, and other Microsoft products.

Why should a Head, Quality Center of Excellence & Business Development Integration Lead use KanBo as a Process Management tool?

As a leader in quality and business development integration, utilizing KanBo can provide a streamlined platform for overseeing and synchronizing quality assurance processes with business development activities. It can help maintain high standards of excellence by enabling effective tracking of quality metrics and development progress while facilitating collaboration among teams. The tool's versatility in project management and its ability to handle complex workflows with customized templates, status tracking, and data analytics makes it a strategic asset for increasing efficiency, reducing errors, and driving continuous improvement in both quality and business development processes.

How to work with KanBo as a Process Management tool

How to Work with KanBo as Process Management in a Business Context for a Head, Quality Center of Excellence & Business Development Integration Lead

1. Create a Workspace for Quality and Business Development Processes

- Purpose: To establish a centralized area for managing quality assurance and business development process activities in alignment with organizational strategic goals.

- Explanation: A workspace serves as the foundation of your process management in KanBo. It allows you to segregate all process-related information, ensures that improvements and communications are in a controlled environment, and aligns team members on common objectives.

2. Define and Categorize Processes in Folders and Spaces

- Purpose: To organize different processes into manageable and identifiable categories.

- Explanation: By categorizing processes in folders, you maintain clarity and segmentation of different process streams (e.g., quality control, compliance reviews, business integration). Within these folders, create Spaces for more granular processes – this granularity allows for enhanced focus and process-specific collaboration.

3. Model Process Flows with Cards and Custom Workflows

- Purpose: To visually represent each step of a process and define the path it takes from initiation to completion.

- Explanation: Use Cards to symbolize individual process tasks and design custom workflows that mirror real-life process steps. This visual modeling aids in identifying bottlenecks, unnecessary steps, and enables process standardization – crucial for optimization.

4. Monitor Process Execution with Card Statuses and Activity Streams

- Purpose: To keep track of progress within each process and ensure that they are operating according to plan.

- Explanation: Card statuses offer real-time insights into where a process is at any given moment. The activity stream logs all actions, providing accountability and historical data for process analysis.

5. Identify and Document Process Blockers

- Purpose: To capture and address any barriers that interrupt the flow of processes.

- Explanation: Utilizing card blockers allows you to spotlight issues promptly. By categorizing blockers (local, global, on-demand), you make the standstill reasons explicit and provide visibility necessary for resolution and process improvement.

6. Execute Process Analysis with Card Relations and Statistics

- Purpose: To understand dependencies and measure the efficiency of process steps.

- Explanation: Card relations illustrate how tasks are interconnected, highlighting dependencies and informing the sequencing of process steps. Card statistics offer analytical data that helps you to gauge process performance and identify optimization opportunities.

7. Fine-Tune Processes with Groupings and Filters

- Purpose: To organize processes for targeted management and quick access to relevant information.

- Explanation: By grouping cards, you can cluster process tasks based on criteria like deadlines or responsible parties, enabling a more focused approach to process management. Filters allow for quick retrieval of specific process information, facilitating rapid decision-making.

8. Optimize Scheduling and Deadlines with Gantt Chart View

- Purpose: To plan and oversee time-sensitive process tasks, ensuring adherence to guidelines and deadlines.

- Explanation: The Gantt Chart view provides a chronological timeline of tasks, supporting better scheduling and highlighting potential overlaps or delays, which are critical for process time management and optimization.

9. Review and Improve Processes with Forecast Charts

- Purpose: To predict process completion times and assess whether processes will meet their intended objectives.

- Explanation: Forecast Charts visualize project progress against historical data, allowing you to make informed decisions on resource allocation and pinpoint areas for improvement, which is essential for continuous process improvement.

10. Standardize and Scale Processes with Templates

- Purpose: To ensure consistency and accelerate the setup of similar processes in the future.

- Explanation: Leverage Space and Card Templates to replicate successful process structures. These templates preserve best practices and make the scaling and replication of optimized processes more efficient.

11. Foster Collaborative Process Improvement

- Purpose: To engage team members in a dynamic, interactive manner for mutual process advancement.

- Explanation: Promoting collaboration through comments, mentions, and real-time updates in KanBo encourages team involvement in refining processes. It also fosters a culture of collective responsibility and continuous improvement.

By integrating KanBo for process management, the Head, Quality Center of Excellence & Business Development Integration Lead, ensures an organized, measurable, and iterative approach to overseeing and enhancing business processes. This systemic management of process optimization aligns closely with strategic objectives, operational efficiency, and sustained organizational growth.

Glossary and terms

Here's a glossary with explanations for various terms related to process management and work-related concepts:

Process Management: The act of governing and improving business processes through various methods to ensure they are efficient and aligned with an organization’s strategic goals.

KanBo: A digital tool designed to aid in work coordination, task management, and team collaboration, integrating with Microsoft ecosystems.

Workspace: A collection of spaces within a process or project management tool where related work activities, projects, or teams are centralized.

Space: An organizational unit within a workspace that contains cards. It typically represents a specific project, phase, or area of focus.

Card: The fundamental unit in many project management and task tracking systems, a card typically represents a task, idea, or item that needs to be managed or tracked.

Card Status: An indicator of the progress or current state of a card (such as "To Do," "In Progress," or "Done").

Card Activity Stream: A real-time log of all updates and interactions with a card, such as comments, status changes, and file attachments.

Card Blocker: A specific issue or obstacle documented on a card that hinders the task's progress.

Card Grouping: The classification of cards within a workspace or space based on certain criteria, such as by status, assignee, or due date.

Card Issue: A problem or challenge associated with a card that affects its completion or management.

Card Relation: A link between two or more cards that establishes dependency or sequence, such as parent-child or predecessor-successor relationships.

Card Statistics: Analytical data that give insights into the card's lifecycle, such as time spent in each status.

Dates in Cards: Calendar-related features on a card that may include start dates, due dates, completion dates, or reminders.

Completion Date: The date when a card's status is marked as completed.

Default Parent Card: In a card relation, the main parent card to which a child card is associated, primarily for tracking progress or workflow.

Forecast Chart View: A visualization tool that projects future progress based on past performance, typically used in project planning and tracking.

Gantt Chart View: A method of showing tasks or events against a timeline. In such a view, tasks are displayed as bars that span from start to end dates.

Grouping: The act of organizing related cards based on defined criteria to streamline workflow management.

List: A category within a workspace or space that allows for grouping of cards.

Understanding these terms and concepts is essential for professionals engaged in tasks related to project management, process improvement, or team collaboration within any business or organizational context.