Digital Product Manager – Deviations & Issue Management QMS Processes

Jobtailor

New Jersey

On-site

USD 150,000 - 200,000

Full time

9 days ago

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Job summary

Jobtailor seeks a senior professional to lead the digitization of Deviations QMS processes within a regulated pharma environment. You will drive implementation of Deviations and Issue Management in Veeva Vault QMS, migrate data from legacy systems, and ensure SAP S/4HANA integration.

You will define the product vision and roadmaps for Deviations capabilities, translate business strategy into IT initiatives, and own requirements and GxP documentation while guiding cross-functional teams in global

Qualifications

10+ years in pharma industry with listed skills
Experience leading large, cross-divisional process improvements
Experience with cloud platform rollouts in regulated environments
Backlog definition with development teams
Leadership in matrix organizations
Hands-on QMS knowledge: Veeva Vault QMS, Trackwise, SAP, Appian
Experience with Deviations AI/ML/Gen AI solutions
Strong SDLC, validation/testing, and regulatory compliance knowledge
Excellent communication, analytical, and change-management skills
Willingness to travel ~10% and work in GMP contexts

Responsibilities

Lead digitization of Deviations QMS processes within QMS.
Lead implementation of Deviations and Issue Management into Veeva Vault QMS.
Migrate processes/data to Veeva Vault QMS with SAP S/4HANA integration.
Define product vision, roadmaps, and value maps for Deviations capabilities.
Translate strategy into prioritized IT/product initiatives with SMEs.
Own requirements, translation to dev, and GxP system docs.
Drive end-to-end delivery of large global cloud deployments.
Lead cross-functional teams and mentor junior members.
Ensure SDLC/GxP-compliant design, testing, and operation.
Govern global design for Deviations solutions; align investments.
Monitor metrics, optimize total cost of ownership.
Lead AI/ML design/delivery for Deviations processes.
Liaise with partners, vendors, and stakeholders; advocate user-centered design.
Influence stakeholders, manage priorities, and enable new ways of working

Skills

Product backlog prioritization

SDLC practices

GxP compliance

Regulatory compliance

Change management

Stakeholder management

Team leadership

Analytical problem solving

Exceptional communication

Deviations Management

Issue Management

AI/ML solutions

Data migration

Cross-functional leadership

Education

Bachelor's degree in computer science, engineering, biology, chemistry, or a related scientific/technical field

Advanced degree (MS or MBA) in a scientific, engineering, or technical discipline

Tools

Veeva Vault QMS

Trackwise

SAP

Appian

UiPath Solutions

SAP S/4HANA

AI/ML Technologies

Job description

Lead digitization of the Deviations QMS process within the Quality Management System
Lead implementation of Deviations Management and Issue Management processes into Veeva QMS Vault
Migrate Deviations QMS processes and data from Appian, UiPath Solutions, and SAP ECC 6.0 to Veeva Vault QMS, integrating with SAP S/4HANA
Define and lead the product vision, value map, and roadmap for Deviations digital capabilities
Translate business strategy into prioritized IT and product initiatives with subject-matter experts and the Investigations Product Owner
Own requirements definition, business-to-development translation, and GxP system documentation
Lead continuous product discovery and maintain a prioritized product backlog
Drive end-to-end delivery of large global cloud-platform implementations in pharma/life sciences
Lead cross-functional, matrixed teams and oversee less senior team members
Ensure systems are designed, developed, tested, and operated in SDLC- and GxP-compliant ways
Govern global process design for Deviations digital solutions
Align investment and portfolio planning with business and technology leaders
Monitor performance, develop metrics, and optimize total cost of ownership
Lead design and delivery of AI/ML capabilities for Deviations processes
Liaise with technology partners, vendors, and stakeholders
Advocate for user-centered design and connect delivery squads with end users
Influence stakeholders, manage conflicting priorities, and support adoption of new ways of working

Requirements

Bachelor’s degree in computer science, engineering, biology, chemistry, or a related scientific/technical field
Minimum of ten (10) years’ experience associated with the listed required skills within the pharmaceutical industry
Experience leading cross-divisional large and complex process improvement initiatives, system implementations, and cloud platform rollouts in regulated environments
Experience defining and prioritizing product backlogs and collaborating with development teams
Leadership of cross-functional internal and external teams in matrix organizations
Hands-on knowledge of Issue Management and Deviations processes and relevant QMS systems, including Veeva Vault QMS, Trackwise, SAP, and Appian
Experience developing, implementing, or managing Deviations Management AI/ML/Gen AI solutions and partnering with data science teams to operationalize models
Strong working knowledge of SDLC practices for GxP systems, validation/testing, and regulatory compliance, including 21 CFR 210/211, ICH, and FDA guidance
Exceptional verbal and written communication skills
Strong analytical and problem-solving skills
Ability to influence without direct authority, manage change, and work effectively in ambiguous, fast-moving environments
Preferred: minimum of five (5) years working at GMP manufacturing sites, technical operations, or other site-level roles with hands-on exposure to Deviations processes
Preferred: five or more (5–10+) years in Deviations, Root Cause Investigations, quality/regulatory, and digital enablement roles
Preferred: experience with DS, DP, FDP End to End Manufacturing, Supply Chain & Logistics, QC Operations, and GCP Operations
Preferred: prior experience with global releases and multi-region deployments in pharma/life sciences
Preferred: advanced degree (MS or MBA) in a scientific, engineering, or technical discipline
No visa sponsorship
10% travel required

Core Competencies

Demonstrates expertise in leading the digitization of Quality Management System processes, particularly in Deviations Management and Issue Management within regulated environments. Proficient in managing cross-functional teams, product backlog prioritization, and ensuring compliance with GxP and SDLC practices.

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