Digital Product Director: Deviations & QMS (GxP, Cloud)

Merck & Co.

West Point (PA)

Hybrid

USD 173,000 - 273,000

Full time

9 days ago

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Benefits offered by this job

401(k) matching

Healthcare coverage

Paid time off

Hybrid work arrangement

Job summary

Merck & Co. is seeking a Digital Product Manager for Deviations & Issue Management QMS to lead the digitization of Deviations QMS processes. You will oversee global cloud platform implementations, partner with site SMEs, and ensure GxP compliance throughout SDLC.

The role emphasizes user-centered design, data-driven decisions, and cross-functional leadership across manufacturing and R&D networks. You will drive product discovery, define roadmaps, and manage backlogs, delivering scalable

Qualifications

Bachelor's degree in computer science, engineering, biology, chemistry, or a related scientific/technical field.
10+ years' pharmaceutical industry experience in the listed required skills.
Proven cross-divisional leadership of large process improvements and cloud deployments in regulated environments.
Experience defining and prioritizing product backlogs with development teams.
Demonstrated matrix leadership and cross-functional collaboration.
Hands-on knowledge of Deviations/Issue Management processes and QMS systems (Veeva Vault QMS, Trackwise, SAP, Appian).
Experience with AI/ML solutions and data science collaboration for operations.
Strong SDLC/GxP regulatory compliance knowledge (21 CFR 210/211, ICH, FDA guidance).
Excellent communication for senior leadership and global stakeholders.
Analytical, data-driven decision-making, and change-management capability.

Responsibilities

Lead cross-functional, cross-divisional teams on Deviations digital capabilities.
Define product vision, value map, and roadmap for Deviations digital capabilities.
Translate business strategy into prioritized IT/product initiatives with SMEs.
Own requirements definition and documentation for GxP systems.
Lead continuous product discovery to surface user needs and backlog prioritization.
Oversee end-to-end delivery of large cloud platform implementations in pharma.
Guide matrix teams and ensure timely product releases with senior oversight.
Ensure IT systems meet SDLC and GxP compliance standards.
Promote IT standards usage (JIRA, Confluence) and release planning.
Align investment and portfolio planning with business and technology leaders.