Senior Business/Industry Technical Advisor-Life Sciences

JOB DESCRIPTION
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.

QUALIFICATIONS

• 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 possible is the standard at UL Solutions. We're able to deliver the best because we employ the best.
• Interesting work: Every day is different for us here as we eagerly anticipate the next innovation that our customers' create. We're inspired to take on the challenge that will transform how people live, work and play. And as a global company, in many roles, you will get international experience working with colleagues around the world.
• Grow & achieve: We learn, work and grow together with targeted development, reward and recognition programs as well as our very own UL University that offers extensive training programs for employees at all stages, including a technical training track for applicable roles.
• Total Rewards: All employees at UL Solutions are eligible for bonus compensation. UL Solutions offers a generous 401k matching structure of up to 5% of eligible pay. Additionally, we invest an additional 4% into your retirement saving fund after your first year of continuous employment. We provide Healthcare Reimbursement Accounts and Health Savings Accounts that UL Solutions contributes to twice per year! Depending on your role, you can work with your manager on flexible working arrangements. We also provide employees with paid time off including vacation, holiday, sick and volunteer time off.

Learn More:
Working at UL Solutions is an exciting journey that twists and turns daily. We thrive in the twists and revel in the turns. This is our every day. This is our normal.
Curious? To learn more about us and the work we do, visit UL.com.
ABOUT US
A global leader in applied safety science, UL Solutions (NYSE: ULS) transforms safety, security and sustainability challenges into opportunities for customers in more than 110 countries. UL Solutions delivers testing, inspection and certification services, together with software products and advisory offerings, that support our customers' product innovation and business growth. The UL Mark serves as a recognized symbol of trust in our customers' products and reflects an unwavering commitment to advancing our safety mission. We help our customers innovate, launch new products and services, navigate global markets and complex supply chains, and grow sustainably and responsibly into the future. Our science is your advantage.
ABOUT THE TEAM
When you combine the gravitas of a 130-year-old safety science leader with the a culture of innovation that pushes the boundaries into new services and technology, you get UL Solutions. As a global team of business and engineering experts, we develop software for a huge range of industries, including medical, sustainability, renewable energy and healthy buildings. Together, we're dedicated to making a real-world difference, to using our knowledge for good and to pioneering positive change. Join our team and use your expertise to transform global safety, security and sustainability.