Digital QMS Product Manager: Deviations & Issues

Merck; West Point (PA); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k)

Paid holidays

Vacation & sick days

Job summary

Merck in the United States (PA, West Point area) seeks a Digital Product Manager for Deviations & Issue Management within the QMS. You will lead cross-functional teams, drive digitization of Deviations management, and deliver large-scale cloud implementations in a regulated pharma environment.

You will own requirements, translate business needs into IT initiatives, partner with SMEs and the Investigations Product Owner, and ensure SDLC/GxP compliance while advancing AI/ML capabilities.

Qualifications

• Bachelor's degree in a scientific/technical field.
• 10+ years in pharma with cross-divisional process improvement experience.
• Experience leading large system implementations in regulated environments.
• Track record of defining and prioritizing product backlogs with development teams.
• Leadership of cross-functional teams in matrix organizations.
• Hands-on knowledge of Deviations/Issue Management and QMS systems (Veeva Vault QMS, Trackwise, SAP, Appian).
• Experience with AI/ML/Gen AI in Deviations management.
• Strong SDLC/GxP regulatory compliance knowledge.

Responsibilities

• Lead Deviations & Issue Management digital capabilities roadmap.
• Define product vision and translate strategy into IT initiatives.
• Oversee cross-functional teams and manage product backlog.
• Ensure SDLC and GxP compliance in IT solutions.
• Partner with SMEs and the Investigations Product Owner.
• Drive AI/ML capabilities for Deviations processes.

Skills

Backlog Management

Product Management

Requirements Management

Strategic Planning

Stakeholder Relationship Management

Organizational Change Management

Education

Bachelor's degree in a scientific/technical field

Tools

Veeva Vault QMS

Trackwise

SAP

Appian

Job description

Merck in the United States (PA, West Point area) seeks a Digital Product Manager for Deviations & Issue Management within the QMS. You will lead cross-functional teams, drive digitization of Deviations management, and deliver large-scale cloud implementations in a regulated pharma environment.

You will own requirements, translate business needs into IT initiatives, partner with SMEs and the Investigations Product Owner, and ensure SDLC/GxP compliance while advancing AI/ML capabilities.