Global Digital Quality Platform Leader

Merck; Upper Gwynedd Township (Montgomery County); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Comprehensive benefits package

Hybrid work model

Job summary

Merck is seeking a senior product leader to own the Digital Quality Product Line across Animal Health Quality, Lab, and IT. You will define a multi-year roadmap and drive global rollout of digital quality and lab products, ensuring regulatory compliance and lifecycle resilience.

Lead cross-functional teams, prioritize backlogs by enterprise value, and explore AI/ML opportunities to enhance decision-making and efficiency across sites. This hybrid role emphasizes strategic vision and execution.

Qualifications

• Bachelor's degree in IT, Engineering, Life Sciences, or related field.
• 7+ years of experience in Quality, Laboratory, Manufacturing, or GxP IT environments.
• Leadership of digital product lines or large-scale platforms in regulated industries.
• Strong knowledge of QMS, LIMS, SDLC, CSV/CSA, and inspection readiness.

Responsibilities

• Own the Digital Quality Product Line vision and multi-year roadmap aligned to Animal Health Quality, Lab, and IT strategies.
• Define and prioritize the product backlog based on enterprise value, regulatory risk, and business outcomes.
• Drive standardization and reuse of digital quality and lab capabilities across sites and regions.
• Lead the design, implementation, and global rollout of Quality and Lab digital products.
• Ensure solutions are fit-for-purpose, compliant, secure, and resilient throughout their lifecycle while maximizing value from existing platforms.
• Ensure adherence to GxP regulations, CSV/CSA, and transition toward CSA / OneCQV-aligned approaches.
• Act as the primary IT partner for Quality and Lab leadership, translating business needs into digital capabilities.
• Drive adoption through change management, training strategies, and communities of practice.
• Lead and develop product owners, solution leads, and delivery teams (internal and external).
• Scan for emerging technologies (AI/ML, automation, analytics) that enhance quality decision-making and lab efficiency.

Skills

Quality Systems

GxP

Regulatory Compliance

Product Leadership

Education

Bachelor's degree in IT/Engineering/Life Sciences

Tools

QMS

LIMS

CSV/CSA

SDLC

Job description

Merck is seeking a senior product leader to own the Digital Quality Product Line across Animal Health Quality, Lab, and IT. You will define a multi-year roadmap and drive global rollout of digital quality and lab products, ensuring regulatory compliance and lifecycle resilience.

Lead cross-functional teams, prioritize backlogs by enterprise value, and explore AI/ML opportunities to enhance decision-making and efficiency across sites. This hybrid role emphasizes strategic vision and execution.