Digital Product Manager (Director) - Deviations & Issue Management QMS Processes
Merck
September 01, 2026
Remote friendly (Rahway, NJ)
United States
Operations
Responsibilities:
- Digital Delivery Lead for implementation of Deviations Management & Issue Management Process into Veeva QMS Vault (migrate deviations process/data from Appian, UiPath, SAP ECC 6.0 to Veeva; integrate with SAP S/4Hana).
- Define and lead product vision/value map/roadmap for Deviations digital capabilities.
- Partner with site/manufacturing/technical operations SMEs and the Investigations Product Owner to translate strategy into IT/product initiatives.
- Own requirements and GxP documentation; lead product discovery and maintain prioritized product backlog.
- Drive end-to-end delivery of global cloud platform implementations; lead cross-functional matrixed teams and oversee product releases.
- Ensure SDLC- and GxP-compliant design/development/testing/operations.
- Champion IT standards/tools (JIRA, Confluence) and release/support planning; govern consistent global process design.
- Drive performance monitoring, metrics, and optimize TCO; lead AI/ML for Deviations.
- Serve as liaison with partners/vendors; advocate user-centered design; act as change agent.
Qualifications:
Required:
- Bachelor’s degree in CS/engineering/biology/chemistry or related technical/scientific field.
- 10+ years pharmaceutical industry experience.
- Proven experience leading cross-divisional process improvement, system implementations, and cloud rollouts in regulated environments.
- Product backlog definition/prioritization experience.
- Leadership in cross-functional matrix organizations.
- Hands-on knowledge of Deviations/Issue Management and QMS systems (Veeva Vault QMS, Trackwise, SAP, Appian).
- Experience with Deviations Management AI/ML/GenAI; partner with data science to operationalize models.
- GxP SDLC/validation/testing and regulatory compliance knowledge (21 CFR 210/211, ICH, FDA guidance).
- Strong communication, analytical/problem-solving, and influence without authority.
Preferred:
- 5+ years at GMP manufacturing sites or site-level Deviations exposure.
- 5–10+ years in Deviations/Root Cause Investigations/quality-regulatory/digital enablement.
- Exposure to DS/DP/FDP end-to-end manufacturing, supply chain/logistics, QC, and GCP operations; global releases/multi-region deployments; MS or MBA.
Benefits/Compensation (as stated):
- Salary range: $173,200.00–$272,600.00; annual bonus/long-term incentive if applicable; medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application:
- Apply via https://jobs.merck.com/us/en (deadline stated on posting).
- Digital Delivery Lead for implementation of Deviations Management & Issue Management Process into Veeva QMS Vault (migrate deviations process/data from Appian, UiPath, SAP ECC 6.0 to Veeva; integrate with SAP S/4Hana).
- Define and lead product vision/value map/roadmap for Deviations digital capabilities.
- Partner with site/manufacturing/technical operations SMEs and the Investigations Product Owner to translate strategy into IT/product initiatives.
- Own requirements and GxP documentation; lead product discovery and maintain prioritized product backlog.
- Drive end-to-end delivery of global cloud platform implementations; lead cross-functional matrixed teams and oversee product releases.
- Ensure SDLC- and GxP-compliant design/development/testing/operations.
- Champion IT standards/tools (JIRA, Confluence) and release/support planning; govern consistent global process design.
- Drive performance monitoring, metrics, and optimize TCO; lead AI/ML for Deviations.
- Serve as liaison with partners/vendors; advocate user-centered design; act as change agent.
Qualifications:
Required:
- Bachelor’s degree in CS/engineering/biology/chemistry or related technical/scientific field.
- 10+ years pharmaceutical industry experience.
- Proven experience leading cross-divisional process improvement, system implementations, and cloud rollouts in regulated environments.
- Product backlog definition/prioritization experience.
- Leadership in cross-functional matrix organizations.
- Hands-on knowledge of Deviations/Issue Management and QMS systems (Veeva Vault QMS, Trackwise, SAP, Appian).
- Experience with Deviations Management AI/ML/GenAI; partner with data science to operationalize models.
- GxP SDLC/validation/testing and regulatory compliance knowledge (21 CFR 210/211, ICH, FDA guidance).
- Strong communication, analytical/problem-solving, and influence without authority.
Preferred:
- 5+ years at GMP manufacturing sites or site-level Deviations exposure.
- 5–10+ years in Deviations/Root Cause Investigations/quality-regulatory/digital enablement.
- Exposure to DS/DP/FDP end-to-end manufacturing, supply chain/logistics, QC, and GCP operations; global releases/multi-region deployments; MS or MBA.
Benefits/Compensation (as stated):
- Salary range: $173,200.00–$272,600.00; annual bonus/long-term incentive if applicable; medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application:
- Apply via https://jobs.merck.com/us/en (deadline stated on posting).