Business Line Lead - Development & Clinical Sample Supply

Business Line Lead

The Business Line Lead (SME) role at Adjutant Solutions Group (ASG) serves as a subject-matter expert, engaging clients to promote, educate, clarify, and communicate the essence of ASG’s capabilities and offerings within the identified business line. Additionally, the Business Line SME role helps ensure technical, regulatory, and operational excellence within their business line. This role bridges business objectives with understanding clients’ needs to deliver compliant, innovative, and high-quality solutions for clients and ASG internal projects. While the SME role follows a consistent governance, collaboration, and shared accountability structure, each SME operates within a unique business line that aligns with ASG’s product lifecycle — from Engineering Research through Post [market] Launch. The business lines are established to optimize market understanding and engagement of ASG products and services.

Development & Clinical Sample Supply

Agile supply of medical device samples with their data is critical path for the evaluation, development and realization of innovative systems to improve quality of life for patients. Shifts in MDR and in QMSR require clinical evidence earlier in the development process to substantiate claims. QbD continues to drive the need for thoughtful studies to assess a designs capability, its maturity and the impact of process on the robustness of the product. Although virtual methods are increasingly used, there is no substitute for actual product.

ASG is establishing business lines to bring focus to critical areas in service to our clients and the marketplace. We are looking for a passionate and committed individual to lead our efforts in sample supply. If you have the ability to advocate for good process, coordinate work with cross functional teams, demand excellence in small batch manufacturing and can bring your design control & configuration management expertise to the team… then this might be the right opportunity for you.

Governance, Reporting & Collaboration

The Business Line SME role reports directly to the Business Marketing Manager to ensure market alignment, business continuity, and client responsiveness across all initiatives. In parallel, the Business Line SME collaborates closely with the Shared Services Manager to ensure alignment with operational standards for resource engagement, compliance requirements, and ASG’s Shared Governance framework.
 

Key Responsibilities:

• Develop and maintain the business line definition and actively promote both externally (clients, marketplace, media) and internally.
• Develop proposals and project concepts for presentation to clients; present to clients as ASG’s authority for the Business Line.
• Integrate Business Marketing and Project Managers to understand owners’ needs, align lifecycle deliverables with business objectives and client priorities to ensure client satisfaction.
• Continue to innovate ASG’s approach to meeting both current and emerging market needs through better process and or identifying and developing new capabilities
• Develop presentations and provide consistency on the ASG’s value proposition message
• Partner with other Business Line leads to simplify the engagement overall engagement and continuity as clients partner with ASG in multiple areas.
• Develop and publish white papers on key issues and trends in the industry for the business line.
• Monitor and be the voice of the team to ensure engagements are appropriately staffed
• Report performance, compliance, and improvement activities to the Shared Services Manager and periodically provide a summary to the business.
• Represent the business line in Governance forums and provide data-driven insights that connect technical work to business outcomes.
• Provide surveillance on competitive activities, gaps in ASG’s capabilities or offerings, and client PAIN points, and work with Shared Services to create solutions

Knowledge, Skills, Abilities & Behaviors

While competencies remain consistent across business lines, proficiency manifests differently depending on the lifecycle phase the SME supports.

Knowledge:

• Proficient understanding of business line principles, ASG’s QMS, and ISO 13485/17025 standards.
• Awareness of client expectations, regulatory requirements, applicable standards, and applicable test or build methodologies.
• Application of risk management principles appropriate for the business line

Skills:

• Skilled in data analysis, problem solving, and interpretation of technical documentation.
•  Proficient in using digital tools (LIMS, eQMS, Smartsheet, Power BI) to document, track, and report progress.
• Strong communication, facilitation, and presentation skills across technical and non-technical audiences.

Abilities:

• Ability to translate complex technical topics into clear, actionable insights for project teams.
• Ability to understand client needs and translate into ASG’s value proposition with supporting capabilities
• Ability to work autonomously while maintaining collaboration and transparency across teams.
• Ability to organize, charter, and launch new projects
• Ability to balance multiple priorities while maintaining focus on quality and compliance outcomes.