Principal Scientist – Software LifeCycle Management ASAT QC System

Principal Scientist – Software Life Cycle Management ASAT QC System Role Summary

• Own the business purpose, intended use, and lifecycle governance for QC method execution system for example; FCS Express, Opus, MyAssay, Matrix etc.
• Define and maintain global standards (configuration, templates, SOPs, training) and ensure consistent adoption across sites.
• Translate business needs into requirements and acceptance criteria; prioritize enhancements, upgrades, and defect resolution with IT and Quality.
• Ensure the validated state is maintained by overseeing change control, validation readiness, and required documentation.
• Own the access model (role-based), periodic access reviews, and business-side controls for data integrity and compliance.
• Act as the business escalation point for risks, issues, and cross-site decisions; communicate roadmap, status, and impacts to stakeholders.

• Expert knowledge of the business processes supported by FCS Express, Opus, MyAssay, Matrix etc., including end-to-end workflows and key user roles.
• Strong understanding of system governance, configuration standards, and template/metadata management required for consistent execution across sites.
• Working knowledge of cGxP, data integrity expectations, and validated system lifecycle practices (requirements, testing/UAT, change control, periodic review).
• Understands cross-functional links and dependencies (Quality, IT, Cybersecurity, site operations, vendors) impacting system performance and compliance.

• Leads cross-site alignment to standardize system use, templates, and configuration to support reliable method execution.
• Owns the business roadmap (enhancements, upgrades, integrations) and coordinates delivery with IT and site stakeholders.
• Ensures requirements, acceptance criteria, and UAT expectations are defined and met before release.
• Provides business oversight for deviations/incidents and supports investigations, root cause, and CAPA follow-through as applicable.

• Works independently to identify needs, define priorities, and drive execution across multiple stakeholders and sites.
• Establishes and runs governance routines (intake, prioritization, decision logs, communications) for the in-scope systems.
• Ensures key documentation is current (standards, SOPs, training, validation deliverables) and accessible for site execution.
• Coordinates with vendors/IT for release planning, testing windows, and deployment readiness to minimize operational impact.

• Makes business decisions on priorities, scope, and tradeoffs balancing compliance, operational needs, and delivery timelines.
• Owns business-side risk identification and mitigation plans (validated state, data integrity, access controls, standardization).
• Serves as the final business escalation point for system issues impacting multiple sites; drives timely resolution with IT and vendors.

• Identifies opportunities to simplify and standardize workflows, templates, and configurations to improve right-first-time execution.
• Drives continuous improvement through metrics, user feedback, and recurring issue trends; prioritizes high-value enhancements.

• Builds strong partnerships with site QC, Quality, IT, LCS and vendors to deliver a stable, compliant, and supported system.
• Leads cross-site communities of practice and training to drive consistent use and knowledge sharing.
• Communicates roadmap, release impacts, and required site actions clearly and in advance.
• Mentors and guides system SMEs and superusers; ensures coverage for key business owner activities.

Princeton, NJ, US: $129,600 - $157,044. The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities may be available based on eligibility.

• Health Coverage:
  Medical, pharmacy, dental, and vision care.
• Wellbeing Support:
  Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-Being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits:
  Paid Time Off, flexible time off (unlimited with manager approval), 11 paid national holidays (with some location exclusions), 160 hours annual paid vacation for new hires, optional holidays, paid sick time, volunteer days, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown.

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