Senior Business/Industry Technical Advisor-Life Sciences

The Senior Business/Industry Advisor position is responsible for delivering consultative solutions in support of UL Solutions’ compliance and learning management system, ComplianceWire.  This is a highly visible role working with potential and existing clients and providing deep expertise in computer system validation, strategic road-mapping, tactical planning, business process reengineering, system implementations, system administration, training program development, and industry best practices for driving culture, primarily in the Life Science Industry.

This position also supports internal system validation projects to assure compliance with applicable regulations, corporate policies, and procedures. This includes assisting in the development of platform validation strategies, documentation, plans and periodic assessments. 

In addition to leading client consulting engagements, this role will work closely with Sales, Marketing, and/or Product Development to develop and document new consulting services products based on changing market conditions, with particular emphasis on solution ideation, design, testing and implementation. This position will also involve the planning, design and execution of pilot programs.

Essential Duties and Responsibilities include (but are not limited to) the following: 

• Provide Subject Matter Expertise on the best practices, configuration optimization, system governance, and validation of the ComplianceWire LMS.
• Support clients with Computerized Systems Validation (CSV) project activities, including planning and developing validation strategies, drafting required validation documentation, and executing validation test scripts.
• Provide guidance and support for our platform CSV framework based on FDA 21 CFR parts 11, 58, 211, 820, GAMP 5 and other regulatory requirements.
• Provide pre-sales analysis/support, elicit client requirements using client meetings, system/document analysis, requirements workshops, etc. and prepare customized Statements of Work (SOW) for required consulting engagements.
• Engage in strategic conversations regarding UL Solutions capabilities and benefits with prospective and/or existing customer constituents.
• Critically evaluate information gathered from multiple sources, reconcile conflicts, synthesize from high-level concepts and/or granular details to a general understanding of client business requirements, distinguishing user requests from the underlying true needs.
• Work in cross-functional teams or independently to deliver the consulting solutions consistently and successfully for clients.
• Manage multiple engagements simultaneously.
• Develop trusting relationships with client and internal UL Solutions personnel.
• Possess strong leadership skills and be interested in growth and development.

• Minimum of seven (7) years of experience working in compliance-based, GxP business environments in the medical device, pharmaceutical, biotechnology, and/or biomedical industry.
• Experience in business-to-business consulting and/or relevant functional experience in the implementation and/or management of systems in a validated environment, particularly in the life sciences industry.
• Extensive knowledge of Computer System Validation (CSV)/Computer Software Assurance (CSA) regulations, requirements, procedures, and best practices for the validation of systems (LMS, Quality, HR, Manufacturing, etc.) serving clients in regulated industries. Applicable government regulations include: FDA 21 CFR parts 11, 58, 211 and 820, Annex 11, GAMP 5 and related multinational industry standards and requirements.
• Experience with training processes and standards required by a company regulated by the FDA preferred.
• Knowledge of Software Development Life Cycle (SDLC) for software applications serving compliance-based business functions.
• Excellent presentation, verbal, and written communication skills along with the ability to interact professionally with a diverse groups, executives, managers, and subject matter experts.
• Bachelor’s degree required, a master’s degree is preferred.

Travel and working conditions:

• Ability to travel up to 25%, as required, by the Business. 

What you’ll experience working at UL:

• Mission: For UL Solutions, corporate and social responsibility isn’t new. Making the world a safer, more secure and sustainable place has been our business model for the last 130 years and is deeply engrained in everything we do.
• People: Ask any UL Solutions employee what they love most about working here, and you’ll almost always hear, “the people.” Going beyond what is