Responsible for NuGenesis SDMS application (Waters) and the Compliance Builder application (Instem) within the Quality, Compliance, and Sustainability (QCS) group.
Serve as the primary liaison between business stakeholders, laboratory operations, and technical teams to deliver compliant, innovative, and efficient digital solutions.
Ensure that laboratory systems and applications meet business needs while adhering to regulatory requirements such as GxP, FDA 21 CFR Part 11, and ISO standards.
Own the vision and prioritization of new features and/or enhancements to a product/platform and help translate business needs into prioritized user stories.
Accountable for value delivery and value realization at the squad level.
Drive the strategic development of digital products by combining strong technical leadership with an understanding of artificial intelligence to identify opportunities, guide innovation and deliver intelligent solutions.
Partner with Product/Platform Managers to define business value, messaging, and stakeholder communication.

Requirements

Bachelor’s degree or equivalent with a minimum of 5 years of related industry experience
2+ years of experience in product ownership or management within a regulated environment
2+ years of experience working with Agile methodologies and tools (i.e. Jira)
Hands-on experience with Laboratory Systems (Scientific Data Management System (SDMS) (preferably Waters NuGenesis), Compliance Builder, or LIMS platforms)
Strong stakeholder management, communication, and decision-making skills
Ability to lead through influence in a global, matrixed environment
Ability to convey complex technical ideas to diverse audiences.
Excellent ability to balance business needs with technical feasibility
Strong knowledge of SDLC methodology, 21 CFR Part 11, GxP and CSV frameworks.
Strong documentation skills for procedures and validation documents.
Skilled at identifying project issues, leading resolution efforts, and ensuring clear understanding of roles and responsibilities within the team for seamless collaboration and project execution.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

product ownershipproduct managementAgile methodologiesScientific Data Management System (SDMS)Compliance BuilderLaboratory Information Management System (LIMS)SDLC methodologyartificial intelligencevalue deliveryvalue realization

Soft Skills

stakeholder managementcommunicationdecision-makingleadershipinfluencetechnical communicationbusiness needs balancingdocumentationproblem-solvingcollaboration